Blood collection devices, systems, and methods

ABSTRACT

In certain instances, an access system can include a connector to couple with a catheter assembly, a reinforcement member fixedly secured to the connector, and a cannula movable relative to the reinforcement member. The cannula can include a polymeric tube and a support tube that encompasses a portion of and is stiffer than the polymeric tube. The support tube can define an inner diameter that is marginally larger than an outer diameter of the polymeric tube to prevent kinking of the polymeric tube and can be in a fixed relationship with the polymeric tube. A distal edge of the support tube is proximally spaced from a distal tip of the polymeric tube and is within the reinforcement member when the distal tip of the polymeric tube is first positioned distal of and external to the reinforcement member as the cannula is advanced.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.17/676,964, filed Feb. 22, 2022, titled BLOOD COLLECTION DEVICES,SYSTEMS, AND METHODS, which is a continuation of U.S. patent applicationSer. No. 17/535,821, filed Nov. 26, 2021, titled BLOOD COLLECTIONDEVICES, SYSTEMS, AND METHODS, which claims priority to each of U.S.Provisional Patent Application No. 63/118,679, filed Nov. 26, 2020,titled BLOOD COLLECTION DEVICES, SYSTEMS, AND METHODS, U.S. ProvisionalPatent Application No. 63/225,992, filed Jul. 27, 2021, titled BLOODCOLLECTION DEVICES, SYSTEMS, AND METHODS, and U.S. Provisional PatentApplication No. 63/256,625, filed Oct. 17, 2021, titled BLOOD COLLECTIONDEVICES, SYSTEMS, AND METHODS; the entire contents of each of theforegoing applications are hereby incorporated by reference herein.

TECHNICAL FIELD

Certain embodiments described herein relate generally to devices,systems, and methods for blood collection and further embodiments relatemore particularly to devices, systems, and methods for facilitatingblood collection via a previously placed catheter, such as, for example,a peripheral intravenous catheter.

BACKGROUND

Known devices, systems, and methods for drawing blood, including drawingblood using a previously placed catheter, suffer from a variety ofdrawbacks. Embodiments disclosed herein remedy, ameliorate, or avoid oneor more of such drawbacks. Other or further uses and methods are alsodisclosed.

BRIEF DESCRIPTION OF THE DRAWINGS

The written disclosure herein describes illustrative embodiments thatare non-limiting and non-exhaustive. Reference is made to certain ofsuch illustrative embodiments that are depicted in the figures, inwhich:

FIG. 1A is a schematic cross-sectional view of a proximal portion of anembodiment of a base catheter system placed within a patient;

FIG. 1B is a schematic cross-sectional view of a distal end of the basecatheter system of FIG. 1A within a blood vessel of a patient;

FIG. 2 is a perspective view of an embodiment of an access systemconfigured to be coupled with an embodiment of a base catheter system,the access system being shown in an undeployed or retracted state;

FIG. 3 is a side elevation view of the access system of FIG. 2 in theundeployed or retracted state;

FIG. 4 is another side elevation view of the access system of FIG. 2 ina fully deployed or advanced state;

FIG. 5 is a cross-sectional view through a longitudinal axis of theaccess system of FIG. 2, with the access system in the fully deployed oradvanced state;

FIG. 6 is a side elevation view of an embodiment of a cannula compatiblewith the access system of FIG. 2;

FIG. 7 is a side elevation view of a distal portion of the access systemof FIG. 2 in the undeployed or retracted state;

FIG. 8 is a cross-sectional view of a distal portion of anotherembodiment of an access system shown in an undeployed or retractedstate;

FIG. 9 is a cross-sectional view of a distal portion of anotherembodiment of an access system shown in an undeployed or retractedstate;

FIG. 10 a cross-sectional view of a distal portion of another embodimentof an access system shown in an undeployed or retracted state;

FIG. 11 a cross-sectional view of a distal portion of another embodimentof an access system shown in an undeployed or retracted state;

FIG. 12 is a perspective view of an embodiment of a closed intravenouscatheter system in a fully assembled state that may be referred to as aninsertion configuration;

FIG. 13 is a perspective view of the closed intravenous catheter systemof FIG. 12 in a state in which a piercing implement has been removedfrom a hub and catheter tube, which state may be referred to as anaccess configuration;

FIG. 14 is a cross-sectional view of a portion of the closed cathetersystem of FIG. 12 in the access configuration;

FIG. 15 is a perspective view of another embodiment of an access systemconfigured to be coupled with embodiments of a base catheter system, theaccess system being shown in an undeployed or retracted state;

FIG. 16 is a cross-sectional view of the access system of FIG. 15 in theundeployed or retracted state;

FIG. 17A is a perspective view of an embodiment of a housing that iscompatible with the access system of FIG. 15;

FIG. 17B is a cross-sectional view of the housing of FIG. 17A;

FIG. 17C is another cross-sectional view of the housing of FIG. 17A;

FIG. 18A is a perspective view of an embodiment of a coupling memberthat is compatible with the access system of FIG. 15;

FIG. 18B is a cross-sectional view of the coupling member of FIG. 18A;

FIG. 19A is a perspective view of an embodiment of a follower that iscompatible with the access system of FIG. 15;

FIG. 19B is another perspective view of the follower of FIG. 19A;

FIG. 19C is a cross-sectional view of the follower of FIG. 19A;

FIG. 20 is a cross-sectional view of an embodiment of a connector thatis compatible with the access system of FIG. 15;

FIG. 21 is a partially exploded elevation view of an embodiment of acannula showing a tie layer separated from a two-component portion ofthe cannula that the tie layer is used to connect together;

FIG. 22 is an enlarged cross-sectional view of the cannula with the tielayer in place over the two-component portion of the cannula;

FIG. 23A is a cross-sectional view of a generally proximal portion ofthe access system of FIG. 15 in a retracted state;

FIG. 23B is a cross-sectional view of a distal portion of the accesssystem of FIG. 15 in the retracted state;

FIG. 24 is an exploded perspective view of an embodiment of a basecatheter assembly that includes an embodiment of an open intravenouscatheter assembly and an embodiment of an extension set that iscouplable to the open intravenous catheter assembly;

FIG. 25 is a cross-sectional view of the base catheter assembly of FIG.24 in an assembled state;

FIG. 26 is a side elevation view of the access system of FIG. 15 in theretracted state coupled with the assembled base catheter assembly ofFIG. 25;

FIG. 27 is a cross-sectional view of a distal portion of the accesssystem of FIG. 15 in the retracted state coupled with the assembled basecatheter assembly of FIG. 25;

FIG. 28 is a cross-sectional view of the access system of FIG. 15 in afully deployed state while coupled with the assembled base catheterassembly of FIG. 25;

FIG. 29A is a cross-sectional view of a generally intermediate portionof the access system while in the configuration depicted in FIG. 28;

FIG. 29B is a cross-sectional view of a generally distal portion of theaccess system of FIG. 15 and a proximal portion of the assembled basecatheter assembly of FIG. 25 while in the configuration depicted in FIG.28;

FIG. 29C is a cross-sectional view of distal ends of the access systemof FIG. 15 and the assembled base catheter assembly of FIG. 25 while inthe configuration depicted in FIG. 28;

FIG. 30 is a perspective view of another embodiment of an access systemconfigured to be coupled with embodiments of a base catheter system,with the access system being shown in a retracted or undeployed state;

FIG. 31 is a cross-sectional view of the access system of FIG. 30;

FIG. 32A is a perspective view of an embodiment of a coupling memberthat is compatible with the access system of FIG. 30;

FIG. 32B is a cross-sectional view of the coupling member of FIG. 32A;

FIG. 33 is a cross-sectional view of a distal end of the access systemof FIG. 30, while in the retracted or undeployed state, being advancedtoward an embodiment of a closed intravenous catheter system, such asthe closed intravenous catheter system of FIG. 12, for couplingtherewith;

FIG. 34 is a cross-sectional view of the distal end of the access systemof FIG. 30, while in the retracted or undeployed state, coupled with theclosed intravenous catheter system;

FIG. 35 is a perspective view of another embodiment of an access systemconfigured to be coupled with embodiments of a base catheter system,with the access system being shown in a retracted or undeployed state;

FIG. 36 is a cross-sectional view of the access system of FIG. 35 in theretracted state;

FIG. 37A is a perspective view of an embodiment of a housing that iscompatible with the access system of FIG. 35;

FIG. 37B is a perspective cross-sectional view of the housing of FIG.37A;

FIG. 38A is a perspective view of an embodiment of a follower that iscompatible with the access system of FIG. 35, the follower including aselective engagement feature;

FIG. 38B is a cross-sectional view of the follower of FIG. 38A;

FIG. 39A is a perspective view of an embodiment of a reinforcing tubeassembly that includes a reinforcing tube and a catch;

FIG. 39B is a cross-sectional view of the reinforcing tube assembly ofFIG. 39A;

FIG. 40 is a cross-sectional view of a distal end of the access systemof FIG. 35 when in the retracted state of FIGS. 35 and 36;

FIG. 41 is a cross-sectional view of a distal region of the accesssystem of FIG. 35 when in the retracted state;

FIG. 42 is a cross-sectional view of an intermediate region of theaccess system of FIG. 35 when in the retracted state;

FIG. 43 is a cross-sectional view of a generally proximal portion of theaccess system of FIG. 35 when in the retracted state;

FIG. 44 is a cross-sectional view of the access system of FIG. 35coupled with an embodiment of a base catheter assembly, such as the basecatheter assembly of FIG. 24, while the access system of FIG. 35 is inthe retracted state;

FIG. 45 is a cross-sectional view of a generally intermediate region ofthe access system of FIG. 35 while in the retracted configurationdepicted in FIG. 44;

FIG. 46 is a cross-sectional view of a distal portion of the accesssystem of FIG. 35 and a proximal portion of the catheter assembly whilethe access system is in the retracted configuration depicted in FIG. 44;

FIG. 47 is a cross-sectional view of the access system of FIG. 35coupled with the base catheter assembly while in a partially deployedstate, or stated otherwise, while in an intermediate stage ofdeployment;

FIG. 48 is a cross-sectional view of an intermediate region of theaccess system of FIG. 35 while in the intermediate deploymentconfiguration depicted in FIG. 47;

FIG. 49 is a cross-sectional view of a distal end of the access systemof FIG. 35 and a proximal portion of the base catheter assembly whilethe access system is in the intermediate deployment configurationdepicted in FIG. 47;

FIG. 50 is a cross-sectional view of the access system of FIG. 35coupled with the base catheter assembly while in a fully deployed state;

FIG. 51 is a cross-sectional view of an intermediate region of theaccess system of FIG. 35 while in the fully deployed state depicted inFIG. 50;

FIG. 52 is a cross-sectional view of a generally distal portion of theaccess system of FIG. 35 and a proximal portion of the base catheterassembly while the access system is in the fully deployed state depictedin FIG. 50;

FIG. 53 is a cross-sectional view of distal ends of the access system ofFIG. 35 and of the base catheter assembly while the access system is inthe fully deployed state depicted in FIG. 50;

FIG. 54 is a perspective view of another embodiment of an access systemin a retracted state;

FIG. 55 is a cross-sectional view of the access system of FIG. 54 in theretracted state;

FIG. 56A is an enlarged cross-sectional view of a distal region of theaccess system of FIG. 54 in the retracted state;

FIG. 56B is an enlarged cross-sectional view of a proximal region of theaccess system of FIG. 54 in the retracted state;

FIG. 57 is a perspective view of another embodiment of an access systemin a retracted state;

FIG. 58 is a cross-sectional view of the access system of FIG. 57;

FIG. 59 is an enlarged cross-sectional view of the access system of FIG.57 taken along the view line 59 in FIG. 58 in which an embodiment of asealing member positioned at a proximal end of a reinforcement tube isshown;

FIG. 60 is a cross-sectional view of another embodiment of a sealingmember compatible with the access system of FIG. 57;

FIG. 61 is a perspective view of another embodiment of an access systemin a retracted state;

FIG. 62 is a cross-sectional view of the access system of FIG. 61 in theretracted state;

FIG. 63 is a perspective cross-sectional view of another embodiment ofan access system; and

FIG. 64 is a cross-sectional view of a generally distal portion of theaccess system of FIG. 63.

DETAILED DESCRIPTION

Embodiments of the present disclosure relate generally to devices,systems, and methods for blood collection (also referred to as blooddraws, blood aspiration, phlebotomy procedures, etc.). The bloodcollection can be achieved via an access system that includes a conduitor cannula that is inserted into a previously placed catheter, such as acatheter tube of a previously placed catheter, such as, for example, apreviously placed peripheral intravenous (PIV) catheter. In certainembodiments, the access system can provide a desirable alternative tovenipuncture.

In one context, fluid, particularly blood, is drawn from patients on aroutine basis in many hospitals, clinics, and laboratories. One of themost common ways to draw blood is venipuncture, which is a method thatinvolves inserting a needle through the skin and into an underlying veinto provide access to the patient's blood. In some instances, blood canbe drawn as frequently as every six hours. Further, patients can besubjected to multiple attempts each time a needle is inserted into theskin, and the more frequent the withdrawals become, the more difficultit can become to find a location for the next withdrawal. Each attemptcan be painful and a nuisance. Difficult intravenous access (DIVA) is acommon problem that affects numerous patients. Other options for thewithdrawal of blood and other fluids, however, are limited, and canoften be even more painful than venipuncture. Some of these optionsinclude the use of peripherally inserted central catheters (PICC lines),central lines, repeated peripheral venipuncture, and groin sticks.

In some instances, blood may be drawn via a peripheral intravenouscatheter at the time of insertion. In many instances, however, clots orfibrin sheaths can form at the tip of an intravenous catheter over time,so it is generally not desirable to draw blood from peripheralintravenous catheters, as previously designed, at any significant timeafter placement. In various instances, the obstructions that form at thedistal tip can fully obstruct the distal tip, thereby entirelypreventing withdrawal of blood through the catheter. In other instances,the obstructions may only partially obstruct the distal tip, but mayaffect fluid flow through the catheter in such a way as to promotehemolysis and/or otherwise reduce the quality of the blood withdrawnthrough the catheter and/or reduce a speed of the withdrawal.

In some instances, the intravenous catheter can lack sufficient rigidityto remain fully patent during a blood draw. For example, in someinstances, the catheter is formed of a material that softens over timewhen within the patient vasculature. While blood draws may be possibleupon initial placement of the catheter, blood draws may becomeincreasingly difficult and ultimately impossible after the initialplacement as the catheter softens. The catheter lumen may collapse whennegative pressure applied at a proximal end of the catheter for anattempted blood draw, thereby inhibiting or preventing blood withdrawal.

In certain instances, even when blood is able to be withdrawn through asoftened catheter, the quality of the drawn blood, relative to thequality of blood drawn immediately after placement of the catheter, maydeteriorate as the catheter softens. Without being bound by theory, thisquality reduction may be due to the lumen defined by the catheterbecoming more tortuous or otherwise changing shape as the cathetersoftens. For example, upon initial placement, the catheter may haverelatively few curves and/or regions of the catheter that extend throughthe skin and the vessel wall may define a rounded cross-sectionalprofile. Over time, the softening or softened catheter may becomecompliant so as to conform to tortuous anatomy through which it passesand/or the cross-sectional profile at the insertion regions may flattenor otherwise change shape. Blood drawn through these altered regionsmay, for example, be more susceptible to hemolysis.

In still other or further instances, an opening at the catheter tip maysuction against a feature of the vessel anatomy, such as a valve or thevessel wall, during an attempted blood draw, thereby preventing bloodwithdrawal through the opening.

For one or more of the foregoing reasons, and/or for other possiblereasons, it can be desirable to provide a conduit or cannula through apreviously placed catheter (e.g., a PIV catheter) to achieve ahigh-quality blood draw through the catheter. The terms “conduit” and“cannula” may be used interchangeably herein. In some instances, thecannula can have sufficient rigidity to provide or maintain a patentlumen through which blood can readily pass. In other or furtherinstances, the cannula can be readily inserted through tortuous pathinto and/or through a blood vessel. In other or further instances, thedistal end of the cannula may be placed distally relative to the tip ofthe previously placed catheter, which may, for example, avoidinterference from clots or fibrin sheaths; permit access to a regionbeyond an otherwise obstructing anatomical feature, such as by movingpast one or more venous valves and/or away from a vessel wall; permitmovement to a region of increased blood flow; and/or move away from aregion of vascular trauma due to venipuncture and catheter insertion,any or all of which can result in substantially improved blood draws,such as, for example, by establishing blood flow and/or by reducinghemolysis of the sampled blood.

Certain embodiments disclosed herein can remedy, ameliorate, or avoidone or more limitations or drawbacks of known systems in which acatheter is inserted through a previously placed catheter for purposesof blood collection. One or more of these and/or other advantages willbe apparent from the present disclosure.

For example, in some instances, a catheter is introduced into a patient,and subsequently, a cannula is introduced into the patient through thecatheter. The catheter may be referred to herein as a placed catheter, apreplaced catheter, an anchor catheter, or a base catheter. The cannulamay, in some instances, also be referred to as a conduit, a fluidchanneler, a fluid extraction member, etc. In many instances, thecannula will have properties different from the placed catheter. Forexample, in some instances, at least a portion of the cannula may bestiffer or more rigid than the placed catheter. The cannula may, in someinstances, define an open lumen or passageway through which blood canpass from the vessel and out of the patient through the cannula into anysuitable blood collection device. The cannula may, in some instances, bereinforced so as to avoid buckling or kinking in order to readily enterand extend through a tortuous path of a lumen defined by the catheter.In some instances, the cannula may straighten or otherwise reduce atortuousness of a path through a preplaced catheter system. In someinstances, the cannula may be advanced past a distal end of the placedcatheter.

FIGS. 1A and 1B depict an embodiment of a base catheter system 100, suchas, for example, a peripheral intravenous (PIV) catheter system. Thebase catheter system 100 may also be referred to herein as a placedcatheter system, a preplaced catheter system, an anchor catheter system,etc. The base catheter system 100 includes a catheter tube 104 and acatheter hub 106 that is fixedly secured to a proximal end of thecatheter tube 104. The base catheter system 100 can be inserted into apatient P in any suitable manner such that at least a distal end of thecatheter tube 104 extends into a vessel V (e.g., a vein) of the patient(FIG. 1B) and such that a proximal portion of the base catheter system100, including the catheter hub 106, is accessible at an exterior of thepatient. The catheter tube 104 can define a lumen 108 through which, forexample, infusions may be delivered into the vessel V. The catheter hub106 may be of any suitable variety. In some embodiments, the catheterhub 106 is a female luer connector.

While not shown in FIG. 1A, in many embodiments, the proximal portion ofthe base catheter system 100 that remains at an exterior of the patientP after placement of the catheter tube 104 can be secured to the skin ofthe patient. A variety of dressing options are possible, including tapeor adhesive dressings that are specifically designed for suchsecurement. As further discussed below, certain embodiments may beusable with the base catheter system 100 when the base catheter system100 has been secured to the patient using a tape or adhesive dressings(e.g., a standard or known dressing), and, in further instances, may beusable with the base catheter system 100 without the use of anyspecialized apparatus (e.g., a wedge-shaped support member) that mightcouple with the base catheter system 100 to position the catheter hub106 and the proximal end of the tube 104 at an angle relative to thesurface of the skin, such as, e.g., at an acute angle similar to thatshown in FIG. 1A.

In some embodiments, the base catheter system 100 can be an opencatheter system, such as an open intravenous catheter system (e.g., anopen PIV catheter system). The term “open” in this context is used inits ordinary sense in the relevant art, and includes catheter systems inwhich the connector 106 may not provide a barrier (e.g., a fluid-tightseal) between the lumen 108 and the environment external to the catheterhub 106. For example, in the illustrated embodiment, the catheter hub106 defines an open proximal end that is exposed to the environment. Insome embodiments, a sealing member, such as any suitable valve, septum,or needleless connector, may be affixed to the catheter hub 106. Inother or further embodiments, an extension set (see, e.g., FIGS. 24 and25) may be coupled with the catheter hub 106. In certain embodiments(such as that depicted in FIG. 24) the extension set can include aconnector at a proximal end thereof, a connector at a distal end thereoffor coupling with the catheter hub 106, and a sideport therebetween withan extension tube and any suitable connector at a proximal end of theextension tube. In some instances, the proximal connector may include orbe coupled with a valve, septum, or needleless connector.

As further discussed below, in other embodiments, the base cathetersystem 100 may instead be a “closed” catheter system, such as a closedintravenous catheter system (e.g., a closed PIV catheter system). Anillustrative example of such a closed intravenous catheter system isdepicted in, and discussed further below, with respect to FIGS. 12-14.The term “closed” in this context is used in its ordinary sense in therelevant art, and includes systems in which the catheter tube 104 isattached to a distal port of a catheter hub 106 that further includes aproximal port, from which an introducer needle can be withdrawn andthereupon sealed or plugged, and an integrated side port in fluidcommunication with the catheter tube 104, via which fluid deliveryand/or removal via the catheter tube 104 is achieved. One illustrativeexample of a closed PIV catheter system is the NEXIVA™ closed IVcatheter system, available from Becton Dickinson.

With reference to FIGS. 2-5, in some embodiments, an access system 200can be configured to couple with the base catheter system 100. Theaccess system 200 may also or alternatively be referred to as an accessassembly. The illustrated access system 200 may be particularly wellsuited for coupling with and/or for operative use in advancing a conduitinto an open base catheter system 100, such as the illustrative system100 depicted in FIGS. 1 and 2. In other or further instances, the accesssystem 200 can be configured to couple with an extension set (e.g., suchas that depicted in FIG. 24) of an open base catheter system 100, andcan advance a conduit through the extension set and ultimately into thecatheter tube 104. The access system 200 can also be referred to as afluid channeling system, a fluid extraction system, a blood removalsystem, a follow-on cannula system, a secondary catheter system, asupplemental catheter system, etc.

The base catheter system 100, such as the catheter tube 104 thereof, canbe inserted into a vessel of a patient in any suitable manner, includingthose known in the art. In some instances, no portion of the accesssystem 200 is coupled with the base catheter system 100 prior toinsertion of the base catheter system 100 into the patient. For example,the access system 200 may be coupled with the base catheter system 100after the base catheter system 100 has been placed within the patient.In particular, one or more portions of the access system 200 may becoupled to the base catheter system 100 at any suitable time afterplacement of the base catheter system 100. In some instances, thesuitable time may be no less than 30 minutes, 1 hour, 6 hours, 12 hours,18 hours, 1 day, 2 days, or 3 days after initial placement of the basecatheter system 100.

The access system 200 includes a connector 202 and a cannula 204. Thecannula 204 may also be referred to as a conduit. The cannula 204 candefine a continuous fluid path through which blood can be extracted fromthe vasculature of a patient. The cannula 204 is configured to moverelative to the connector 202 between a retracted or undeployed state(FIGS. 2 and 3) and an advanced or deployed state (FIGS. 4 and 5). Inparticular, a user can grip the cannula 204—e.g., a proximal end of thecannula 204—to distally advance (e.g., translate forwardly) the cannula204 relative to the connector 202 from the retracted state to theadvanced state. Likewise, the user can grip the cannula 204—e.g., theproximal end of the cannula 204—to retract proximally (e.g., translaterearwardly) the cannula 204 relative to the connector 202 from theadvanced state back to the retracted state. For example, in someinstances, the user can grip a connector 229 at a proximal end of thecannula 204 to advance and/or retract the cannula 204.

The connector 202 can include a coupling interface 210, which can be ata distal end of the connector 202. In the illustrated embodiment, thecoupling interface 210 includes a threaded male luer interface 211, suchas may readily couple with a female luer interface of the catheter hub106 described above. Any other suitable coupling interface 210 iscontemplated.

The connector 202 may be longitudinally elongated so as to besubstantially tubular in shape. For example, in some embodiments, adistal end of the connector 202 may include a connection region 203 at adistal end thereof that defines the coupling interface 210, and canfurther include a housing, barrel, tube, or sheath 205 that extendsproximally from the connection region 203. The sheath 205 can define anextended channel 212 (FIG. 5), which may also be referred to as an innerchamber, cavity, or interior space, within which a portion of thecannula 204 may be positioned. For example, in various embodiments, atleast some portion of the cannula 204 may be positioned within orinternal to the sheath 205 when the cannula 204 is in the retractedstate, the deployed state, and throughout transitioning between theretracted and deployed states.

With reference to FIGS. 5 and 6, in various embodiments, the cannula 204can be a multi-part or multi-segment component. For example, in theillustrated embodiment, the cannula 204 is a three-segment element thatdefines a continuous or uninterrupted flow path or fluid path 220 forblood draws. In the illustrated embodiment, each segment is defined by aseparate piece, with each piece being formed of one or more materialsthat are different from materials of one or more of the other twopieces. In other embodiments, two or more of the multiple segments(e.g., the proximal and medial segments) may be integrally formed of aunitary piece of material. In still other or further embodiments, eachsegment may include one or multiple components or constituent elements.In certain of these embodiments, either two or all three of the segmentsmay have at least one component that differs in some manner from each ofthe remaining segments, such as, for example, by way of physicalproperty, number, presence or absence, etc. The fluid path 220 caninclude a lumen 221. In some embodiments, the lumen 221 can vary indiameter along a length of the cannula 204. For example, in theillustrated embodiment, the lumen 221 defines a larger inner diameter ina proximal region of the cannula 204, as compared to a distal regionthereof. In other embodiments, the lumen 221 may define a substantiallyconstant inner diameter along substantially a full length of the cannula204.

In some embodiments, the cannula 204 can include a proximal segment 222,a middle, intermediate, or medial segment 224, and a distal segment 226,as identified in FIG. 6. In some embodiments, the materials and/ormaterial properties of at least one of the segments can vary relative tothat or those of one or more of the remaining segments.

In certain embodiments, the proximal segment 222 can be rigid orsemi-rigid. The proximal segment 222 can be formed of a clear plastic,for example, which can allow for visualization of fluid flow. Rigidityof the proximal segment 222 can allow for the cannula 204 to be pusheddistally relative to the connector 202. In some embodiments, theproximal segment 222 can include the connector 229 at the proximal endthereof. The connector 229 can be of any suitable variety. For example,in the illustrated embodiment, the proximal segment 222 includes aconnector 229 that is a female luer connector (i.e., compliant with ISOstandards), which can be connected to any suitable any suitable fluidsource and/or fluid collection device. For example, the connector 229can be configured to couple with a syringe, which may be used forinfusion or blood collection. The connector 229 may be used forconnection to blood draw apparatus, such as syringes or evacuated bloodcollection tubes (e.g., Vacutainer® tubes available from BectonDickinson) and/or apparatus therefor. For example, in some embodiments,the connector 229 may include or may be configured to connect with aVacutainer® one-use holder, via which blood draws may be made into oneor more Vacutainer® tubes. In other embodiments, the connector 229 maybe integrally formed with a fluid source and/or a fluid collectionapparatus.

In some embodiments, a valve or vent fitting may be removably attachedto or incorporated into the proximal segment 222. A vent fitting (suchas, e.g., the vent fitting 819 depicted in FIG. 12) can, for example,permit blood flow from the vasculature through the cannula 204 as airwithin the cannula lumen 221 is vented to the environment, and the ventfitting can serve as a liquid-impervious barrier to the blood. In someembodiments, the proximal segment 222 can allow visualization of aninitial passage of blood through the lumen 221, or stated otherwise, canprovide blood flashback visualization. For example, when the proximalsegment 222 includes a tube of clear or translucent material, theproximal segment 222 can allow for potential visualization of bloodflashback. In various embodiments, the proximal segment 222 can includeor be formed of a tube of polycarbonate, polyurethane, and/orpolypropylene. Any other or further suitable material is contemplated.

In some embodiments, the proximal segment 222 may be flexible intransverse directions, relative to a longitudinal axis of the proximalsegment 222, yet may have sufficient rigidity in a longitudinaldirection to transfer distal forces along the cannula 204. For example,in some embodiments, the proximal segment 222 may be sufficientlyflexible to bend up to about 90, 120, 150, or 180 degrees, e.g., withoutplastically deforming, yet can be straightened and advanced distally toadvance the cannula 204 distally relative to the connector 202. In someinstances, the proximal segment 222 can be packaged in a bent state,which can permit reduction of a total length of packaging for aprepackaged access system 200. A user can remove the access system 200from the packaging and either manually unbend the proximal segment 222or permit the proximal segment 222 to resiliently straighten to arelaxed state, which may be substantially rectilinear. Stated otherwise,in some embodiments, the proximal segment 222 may be resilientlydeformable and may naturally unbend to a substantially straightconfiguration upon removal from the packaging. The user can advance thestraightened proximal segment 222 through the proximal end of the sheath203 to advance the cannula 204 distally relative to the connector 202.

In other embodiments, the proximal segment 222 may be relatively rigid.The proximal segment 222 may have a rectilinear configuration, such asdepicted in FIG. 6, and may be relatively resistant to lateraldeformation from the rectilinear shape. For example, the proximalsegment 222 may be preformed, packaged, and usable in the rectilinearshape, and in further embodiments, may be substantially resistant todeformations from the rectilinear shape.

In certain embodiments, the medial segment 224 of the cannula 204 can bestiff or rigid so as to avoid bending or kinking. The medial segment 224can transfer distal forces from the proximal segment 222 to the distalsegment 226. In various embodiments, the medial segment 224 may includeor be formed of metal, such as, for example, stainless steel. Forexample, in some embodiments, the medial segment 224 consistssubstantially of a metallic tube, such as a hypotube, that is coupled tothe distal segment 226. In other embodiments, the medial segmentincludes a metallic tube, such as a hypotube, that encompasses a portionof a polymeric tube that extends through a lumen of the metallic tube.Other or further suitable materials and/or configurations are alsocontemplated.

The proximal segment 222 and the medial segment 224 may be joinedtogether in any suitable manner. For example, in various embodiments,the proximal segment 222 may be overmolded over a proximal end of themedial segment 224. In other embodiments, the proximal and medialsegments 222, 224 may be press-fit, friction-fit, adhered, or otherwisejoined together, and may be fluidically sealed such that no leakage fromthe lumen 221 occurs at the interface between these two segments.

The distal segment 226 may be relatively soft or flexible so as toreadily advance through the preplaced catheter 104. For example, thedistal segment 226 can be substantially softer and/or more flexible(e.g., can be laterally deflected much easier) than the medial segment224. For example, the distal segment 226 may be sufficiently soft orflexible to prevent or inhibit damage to the catheter tube 104 and/or,in certain embodiments, the blood vessel V (e.g., should the distalsegment 226 be extended past the distal end of the catheter tube 104 andcome into contact with the blood vessel V). Nevertheless, in variousembodiments, the distal segment 226 may be sufficiently rigid to beadvanced through the catheter tube 104. In some embodiments, the distalsegment 226 may render the catheter tube 104 straighter as the distalsegment 226 is advanced therethrough.

In some embodiments, a distal tip 227 of the distal segment 226 includesone or more features that render the distal tip 227 atraumatic, orsubstantially atraumatic, relative to one or more of the preplacedcatheter tube 104 and the patient vasculature. For example, in someembodiments, the distal segment 226 comprises a tube of polymericmaterial (e.g., polyimide). In some embodiments, the distal tip 227 ofthe tube is laser ablated so as to smooth and round the tip, thusrendering the distal tip 227 less prone to scraping, scratching,cutting, and/or puncturing an inner surface of the catheter tube 104and/or a vessel within which the catheter tube 104 is positioned whenthe distal tip 227 extends from the catheter tube 104. In other orfurther embodiments, the distal tip 227 can include a softer materialattached to a distal end of the polymeric tube (e.g., a material with alower durometer). For example, in some embodiments, a silicone layer maybe positioned at the distal tip 227 in any suitable manner.

The distal segment 226 may be fully positioned within the catheter tube104 when the cannula 204 is in the advanced state, such that the distaltip 227 is proximally recessed or generally flush with a distal tip ofthe catheter tube 104, or the distal segment 226 may extend slightlybeyond the distal tip of the catheter tube 104, during a blood draw. Thedistal segment 226 can conform to a tortuous path of the vasculatureand/or defined by the preplaced catheter system 100 when a portion ofthe catheter system 100 (i.e., at least a portion of the catheter tube104) is positioned within the vasculature. The distal segment 226 canprevent damage to the catheter tube 104, e.g., during advancementtherethrough. For example, if the catheter tube 104 is sharply bent orkinked, the distal segment 226 can avoid puncturing through or scrapingan interior of the catheter tube 104 at the bent or kinked site duringdistal advancement of the distal segment 226 through the catheter tube104.

In various embodiments, the distal segment 226 can include or be formedof polyimide, polyether block amide, silicone, polyamide, nylon, PEEK,and/or polyurethane. In other or further embodiments, the distal segmentcan comprise a siliconized polyurethane, such as one or more of thematerials described in U.S. Patent Application Publication No.2019/0153147 to Muse et al., the entire contents of which are herebyincorporated by reference herein. Any other or further suitable materialis also contemplated.

In some embodiments, the distal segment 226 can have sufficient rigidityto at least partially straighten out the catheter tube 104 of the system100 as the distal segment 226 is advanced through the catheter tube 104.For example, in some embodiments, the distal segment 226 can have astiffness that is greater than the stiffness of the catheter tube 104.Straightening via the distal segment may, in some instances, facilitateblood withdrawal and/or permit laminar or substantially laminar bloodflow through the cannula 204. Stated otherwise, the distal segment 226can provide a straight or straightened flow path, relative to a flowpath that is defined by the preplaced catheter system 100 prior to useof the system 200. For example, in some instances, the fluid path 220through the deployed system 200 can be substantially straight orrectilinear, or can be gently sloped or gradually bent (e.g., withoutsharp turns or kinking) along the length of at least the distal segment226 when the system 200 is deployed within the preplaced catheter system100. The distal segment 226, or at least a distal portion thereof, canbe sized to slide or otherwise be advanced through the lumen 108 of thecatheter tube 104.

In other embodiments, the distal segment 226 may be relatively softerthan embodiments that might achieve significant straightening of apre-placed catheter tube. In various embodiments, the distal segment mayachieve a lower amount, a minimal amount, or even substantially nostraightening of the preplaced catheter tube 104. A relatively softerdistal segment 226 may nevertheless be able to follow a tortuous paththrough the catheter system 100 while maintaining patency of the lumen221 therethrough. In some embodiments, lateral support provided to thedistal segment 226 by a reinforcement member included in the connector202 and/or strength and kink-resistance afforded by the medial segment224 can assist in advancing the distal segment 226 into the cathetertube 104, as further discussed below.

The distal segment 226 may be joined with the medial segment 224 in anysuitable manner. For example, in some embodiments, the medial segment224 and the distal segment 226 are attached via a length of thin-walledheat shrink tubing (see, e.g., FIGS. 21 and 22). Such an attachmentmechanism may be particularly useful, e.g., when the medial segment 224includes a metal (e.g., stainless steel) tube and the distal segment 226includes a polymeric tube that abuts the metal tube. Any other orfurther suitable attachment is contemplated.

In some embodiments, only the distal segment 226 is introduced into andpasses through the preplaced catheter tube 104. Stated otherwise, whenthe access system 200 is in a fully deployed state, the distal end ofthe medial segment 224 remains proximal to the proximal end of thecatheter tube 104, and at least a portion of the distal segment 226extends into and/or through catheter tube 104. As previously stated, inat least some embodiments, a distal end of the distal segment 226 canextend distally past a distal tip of the catheter tube 104 when theaccess system 200 is in the fully deployed state.

In other embodiments, the distal segment 226 may be relatively shorterand may function as a substantially atraumatic tip for the medialsegment 224, and at least a portion of the medial segment 224 may beintroduced into the catheter tube 104. In some embodiments, the medialsegment 224 can provide a straightened path through at least a proximalportion of the catheter tube 104. For example, the distal segment 226can include any of the tip features previously discussed and may aid inpreventing trauma to the catheter and the blood vessel, and the medialsegment 224 can straighten out at least a portion of the catheter tube104 of the system 100 as the medial segment 224 is advanced through thisat least a portion of the catheter tube 104. This straightening mayfacilitate blood withdrawal and/or achieve laminar or substantiallylaminar blood flow through the cannula 204. Stated otherwise, in variousembodiments, the medial segment 224, whether alone or in combinationwith the distal segment 226, can provide a straight or straightened flowpath, relative to a flow path that is defined by the preplaced cathetersystem 100 prior to use of the system 200. For example, the fluid path220 through the deployed system 200 can be substantially straight orrectilinear, or can be gently sloped or gradually bent (e.g., withoutsharp turns or kinking) along the length of at least the medial segment224 when the system 200 is deployed within the preplaced catheter system100. The medial segment 224, or at least a distal portion thereof, canbe sized to slide or otherwise be advanced through at least a portion ofthe lumen 108 of the catheter tube 104.

In other embodiments, as further discussed below, the medial segment 224may not extend into the catheter tube 104. For example, in someembodiments, an outer diameter of the medial segment 224 is larger thanan inner diameter of the catheter tube 104 and may be prevented fromentering the proximal end of the catheter tube 104.

With reference to FIG. 7, in some embodiments, the connector 202includes a reinforcing member 230, which may also or alternatively bereferred to herein as a reinforcement member. In the illustratedembodiment, the reinforcing member 230 comprises a tubular member, suchas a needle-like element or reinforcing cannula 232. The reinforcingcannula 232 may also or alternatively be referred to herein as areinforcing tube. In some embodiments, the reinforcing cannula 232 maybe formed from a metallic hypotube. The reinforcing member 230 canprovide external or lateral support to the distal segment 226 to preventbuckling and/or kinking of the distal segment 226 during forwardadvancement of the cannula 204. For example, in various embodiments, thedistal tip 227 of the distal segment 226 can encounter resistive forcesas the distal segment 226 is advanced distally into the catheter tube104. In particular, during such distal advancement, distally directedforces can be provided to a proximal end of the distal segment 226 bythe relatively stiffer or reinforced (e.g., axially or longitudinallystrengthened) medial segment 224, and the forces that are resistive todistal advancement of the distal segment 226 can tend to act ingenerally the opposite direction (e.g., generally proximally) at thedistal end of the distal segment 226. These generally oppositelydirected forces can tend to compress the distal segment 226, causing thedistal segment 226 to buckle, bow, bend, kink, or displace laterally.The reinforcing member 230 can counter these lateral forces, therebypreventing buckling or kinking and facilitating insertion of the distalsegment 226 into and through the catheter tube 104.

The inner diameter of the reinforcing cannula 232 can be such that theouter diameter of each of the distal segment 226 and at least a distalportion of the medial segment 224 can fit therein. The fit may desirablybe relatively close, such that there is minimal clearance between theinner surface of the reinforcing member 230 and the outer surface ofeach of the distal and medial segments 226, 224. In various embodiments,an inner diameter (e.g., a maximum transverse dimension of an innerperimeter, circumference, and/or profile) of the reinforcement member230 may be larger than an outer diameter (e.g., a maximum transversedimension of an outer perimeter, circumference, and/or profile) of atleast one of the distal and medial segments 226, 224 by no more than 5,10, 15, 20, 25, or 30 percent. In certain embodiments, the cannula 204can be said to slide through the reinforcing cannula 232 duringadvancement and withdrawal (e.g., transitions between the retracted andadvanced states).

In the illustrated embodiment, the reinforcing cannula 232 fully coversor encompasses the distal segment 226 in the fully retracted state,which may also be referred to as the set, ready, initial, pre-deployed,or proximal state, position, orientation, or configuration. The deployedstate may also or alternatively be referred to as an advanced, active,or distal state, position, orientation, or configuration. In someembodiments, a proximal tip of the distal segment 226 and a distal tipof the medial segment 224 may be positioned within the reinforcingcannula 232 when in the retracted state, as shown.

Stated otherwise, in some embodiments, the medial segment 224 canterminate at a distal terminus 250, which may correspond with thedistalmost tip of the medial segment 224. In the illustrated embodiment,the medial segment 224 includes a tubular member having a substantiallyflat or planar transversely oriented face at the distal terminus 250.This transverse face abuts a substantially flat or planer transverselyoriented face at a proximal tip of a tubular member of the distalsegment 226. As previously discussed, in some embodiments, a heat shrinktube can extend over these abutting surfaces, which can join or assistin joining the medial and distal tubular members to each other. Statedotherwise, in some embodiments, the medial and distal segments 224, 226are joined at an interface 252, which in the illustrated embodiment,includes abutting surfaces of medial and distal tubes or tubularmembers. The heat-shrink tubing (see, e.g., feature 1080 in FIGS. 21 and22) can extend over these abutting surfaces at the interface 252, orstated otherwise, can extend over the interface 252.

With continued reference to FIG. 7, when the cannula 204 is in theretracted, initial, or set position, the distal terminus 250 and/or theinterface 252 can be positioned within the reinforcement member 230.This can ensure that the full length of the distal segment 226 isreinforced when the distal tip 227 begins to encounter resistance todistal advancement of the cannula 204. For example, as shown in FIG. 7,in the illustrated embodiment, the distal tip 227 of the distal segment226 of the cannula 204 is substantially flush with or slightly recessedrelative to a distal tip of the reinforcing tube 232 when the cannula204 is in the retracted position, and a proximal tip of the distalsegment 226 is at the interface 252, which is likewise positioned withinthe reinforcing tube 232. Accordingly, as soon as the cannula 204 beginsto advance distally, the distal tip 227 of the cannula 204 advancesdistally past the distal tip of the reinforcing tube 232 and may, insome instances, be susceptible to encountering resistive forces, such asby coming into contact with a portion of the pre-placed catheter tube104 that is kinked, bent, curved, or otherwise poses resistance topassage therethrough. In such instances, by positioning the distalterminus 250 of the medial segment 224, or stated otherwise, bypositioning the interface 252 of the medial and distal segments 224,226, within the reinforcement member 230, when the cannula 204 is in thefully retracted position, it can be ensured that the proximal end of thedistal segment 226 is laterally supported by the reinforcement member230 as soon as the distal tip 227 is exposed. Likewise, a full length ofwhatever portion of the distal segment 226 that remains within thereinforcement member 230 can be reinforced as the distal segment 226 isadvanced distally out of the reinforcement member 230. In certainembodiments, to achieve lateral support of the distal segment 226 asjust described, a length of the reinforcement member 230, and/or alength of the distal segment 226 that is positioned within thereinforcement member 230 when in the set position, can be greater than adistance between a distal tip of the reinforcement member 230 at aposition at which the distal segment 226 initially encounters forcesresistive to distal advancement as the distal segment 226 is deployedfrom the set position.

In other embodiments, the distal tip 227 of the distal segment 226 maybe proximally recessed within the reinforcement member 230 by a moresignificant distance (e.g., by a length that is approximately equal to,or that is on the order of two, three, four or more times greater than,an outer diameter of the distal segment 226) when the cannula 204 is inthe fully retracted position. In some embodiments, the interface 252 maybe positioned proximal to a proximal end of the reinforcement member 230when the cannula 204 is in the fully retracted position, whereas inother embodiments, the interface 252 may be positioned within thereinforcement member 230 when the cannula 204 is in the fully retractedposition. In either case, in various embodiments, the interface 252 maydesirably be positioned within the reinforcement member 230 when thedistal tip 227 is first positioned distal of and external to thereinforcement member 230. For example, when the cannula 204 is in thefully retracted position, the interface 252 may be positioned proximalto a proximal tip of the reinforcement member 230 by a distance that isless than or equal to a distance by which the distal tip 227 is recessedrelative to a distal tip of the reinforcement member 230. Thus, as thecannula 204 is advanced distally, the interface 252 may enter into theproximal end of the reinforcement member 230 at the same time as orearlier than the distal tip 227 exits distally out of the distal end ofthe reinforcement member 230.

In certain embodiments, the medial segment 224 is sufficiently rigid toindependently avoid buckling and/or kinking as the distal segment 226 isadvanced through the reinforcing cannula 232 and into and through thepreplaced catheter tube 104. For example, an unsupported length of themedial segment 224, relative to the reinforcing cannula 232 (e.g., aportion of the medial segment 224 that is external to the reinforcingcannula 232) can be self-supporting, intrinsically supported, orotherwise sufficiently rigid avoid buckling and/or kinking that mightotherwise occur if the medial segment 224 were instead formed solely ofthe same material and geometric configuration as the distal segment226—e.g., if the medial and distal segments 224, 226 were formed of acontinuous tube of a single material of uniform construction (e.g.,uniform hardness, thickness, and diameter) and the medial segment 224were not reinforced, or stated otherwise, if the medial segment 224consisted solely of a continuous extension of the soft and/or flexibledistal segment 226. Whereas the medial segment 224 may be “unsupported,”such as by not having a reinforcing or support structure that isexternal thereto, the medial segment 224 may nevertheless beself-supported. For example, a portion of the medial segment 224positioned proximal to the reinforcing member 230 may not be reinforcedor supported by the reinforcing member 230, but may nevertheless beintrinsically supported, e.g., due to its intrinsic rigidity.

For example, in order to transition the cannula 204 from the retractedposition to the advanced or deployed position, distally directed forcesare applied to the proximal segment 222 of the cannula 204, or statedmore generally, are applied to the proximal end of the cannula 204.These distally directed forces tend to urge the medial segment 224 andthe distal segment 226 distally. When the distal segment 226 encountersresistive forces to its distal advancement, these resistive or opposingforces are transferred proximally through the cannula 204. Accordingly,during such advancement and resistance events, the medial segment 224encounters opposing forces at its proximal and distal ends. Theseopposing or compressive forces could tend to bend, kink, or otherwiselaterally deflect, e.g., intermediate regions of the medial segment 224that are external to and unsupported by the reinforcement member 230.However, the medial segment 224 can be configured to withstanddeflection from the opposing or compressive forces. For example, aspreviously discussed, in some embodiments, the medial segment 224 isformed of a rigid material, such as stainless steel, that has sufficientintrinsic strength to resist the compressive forces without bending (orby bending by insignificant amounts) and/or without buckling or kinking.Stated otherwise, the medial segment 224 may be self-reinforced,internally reinforced, or intrinsically reinforced, such that a fulllength of the medial segment 224, whether positioned within or withoutthe reinforcement member 230, may be said to be reinforced.

In other or further embodiments, the medial segment 224 may include aseparate reinforcement or support component, such as a support tube, asdiscussed further below (see, e.g., FIGS. 56A, 56B, and 59 andaccompanying text). For example, in some embodiments, the distal andmedial segments 226, 224 may include a continuous polymeric tube ofuniform properties and dimensions that spans a full length of each ofthe distal and medial segments 226, 224. The medial segment 224 canadditionally include a reinforcement or support tube that encompassesthe polymeric tube. The support tube may have an inner surface that isonly slightly larger than, is marginally larger than, and/or thatclosely conforms to an outer surface of the polymeric tube. For example,in various embodiments, an inner diameter (e.g., a maximum transversedimension of an inner perimeter, circumference, and/or profile) of thesupport tube may be larger than an outer diameter (e.g., a maximumtransverse dimension of an outer perimeter, circumference, and/orprofile) of the inner polymeric tube by no more than 5, 10, 15, 20, 25,or 30 percent. As further discussed below, the support tube may befixedly secured to and/or relative to the polymeric tube.

The support tube can have a distal end positioned within thereinforcement member 230 when the cannula 204 is in the retracted state.The support tube can slide within the reinforcement member 230 as thecannula 204 is advanced distally. As compressive forces arise atopposite ends of the inner polymeric tube during distal advancementthereof, the support tube can generally maintain a rectilinear profileof the portion of the polymeric tube that is positioned therein. Statedotherwise, the relatively stiffer support tube can resist deflection,bending, buckling, or kinking of the inner polymeric tube. As withembodiments discussed in the previous paragraph, the medial segment 224can be said to withstand deflection from the opposing or compressiveforces. For example, the support tube can be formed of a rigid material,such as stainless steel, that has sufficient strength to counterdeflection of the inner polymeric tube as it encounters compressiveforces that would tend to cause the polymeric tube to deflect, bend,buckle, or kink. The support tube can thereby prevent bending (or permitbending by insignificant amounts) buckling or kinking of the innerpolymeric tube. Stated otherwise, the medial segment 224 may beself-reinforced or intrinsically reinforced, such that a full length ofthe medial segment 224, whether positioned within or without thereinforcement member 230, may be said to be reinforced.

In view of the foregoing discussion, at least a portion of the distalsegment 226 can be reinforced when the cannula 204 is in the retractedstate or set position, which reinforcement can be provided by thereinforcement member 230 of the connector 202. Further, at least aportion of the medial segment 224 can be reinforced when the cannula 204is in the retracted state or set position, which reinforcement can beprovided intrinsically, such as by a tube of relatively stiff or rigidmaterial that unitarily constitutes the medial segment 224 or such as bya tube of relatively stiff or rigid material that supports a length of apolymeric tube that is positioned within the relatively stiff tube inthe region of the medial segment 224. In further instances, at least adistal end of the medial segment 224 may be reinforced externally by thereinforcement member 230 when the cannula 204 is in the retraced state.Thus, more generally, a length of the cannula 204 that is positionedwithin the connector 202, such as within the connection region 203 andthe sheath 205, can be reinforced. In various embodiments, a reinforcedlength of the cannula 204, when in the retracted state, can be no lessthan 50, 60, 70, 80, or 90 percent of a total length of the connector202. In other or further embodiments, a reinforced length of the cannula204, when in the retracted state, can be no less than 50, 60, 70, 80, or90 percent of a total length of the sheath 205. In still other orfurther embodiments, a reinforced length of the cannula 204, when in theretracted state, can be no less than 50, 60, 70, 80, or 90 percent of alength of the internal cavity 212 of the sheath 205. In still other orfurther embodiments, a reinforced length of the cannula 204, when in theretracted state, can be no less than 50, 60, 70, 80, or 90 percent of adistance between a proximal end of the reinforcement member 230 and aproximal end of the internal cavity 212 of the sheath 205.

Moreover, in view of the foregoing discussion, a substantial length ofthe cannula 204 can be reinforced throughout movement of the cannula 204from the retracted position to the fully deployed position. Thereinforced length may vary throughout at least a portion of thedeployment event, such as when increasing amounts of the distal segment226 exit from the distal end of the reinforcement member 230. In variousembodiments, a reinforced length of the cannula 204 varies throughout atleast a portion of a deployment event in which the cannula 204 is movedfrom the retracted state to the fully deployed state, and a minimumreinforced length of the cannula 204 throughout a full deployment eventcan be no less than 20, 25, 30, 35, 40, 45, 50, 55, 60, 65, 70, or 75percent of a total length of the cannula 204. The total length of thecannula 204 can be defined, for example, as a distance between thedistal tip 227 of the cannula 204 and the proximal tip of the connector229 (see FIG. 6). In many embodiments, the minimum reinforced length maybe achieved when the cannula 204 is in the fully deployed state.

With continued reference to FIG. 7, the reinforcing cannula 232 may beformed of any suitable material. For example, the reinforcing cannula232 can include or be formed of stainless steel and/or rigid plastic. Insome embodiments, the reinforcing cannula 232 can be formed of ametallic hypotube. The reinforcing cannula 232 may be attached to theconnector 202 in any suitable manner, such as, for example, viapress-fit, bonding, or overmolding. For example, in the illustratedembodiment, the connector 230 comprises a polymeric material that isovermolded onto the reinforcing cannula 232.

In other embodiments, the reinforcing cannula 232 is omitted. Forexample, the reinforcing member 230 may instead be formed as a channelor lumen that extends through, e.g., a distal end of the connector 202.In some embodiments, the distal end of the connector 202 may be moldedor otherwise formed with additional material (e.g., polymeric material),as compared with what is shown in FIG. 7, through which the channel orlumen that forms the reinforcing member 230 extends. For example, insome embodiments, at least a portion of the distal end of the connector202, which includes the connection interface 210, may be extendedlongitudinally in the proximal direction to define an elongatedreinforcing member 230. This alternative reinforcing member may, forexample, have the same length as that of the reinforcing tube 232depicted in FIG. 7, but may instead be formed from additional polymericmaterial with a lumen extending therethrough.

With reference again to FIGS. 5 and 6, in some embodiments, the system200 can include a friction or resistance element 240, which can resist,regulate, temper, adjust, or otherwise passively respond to relativemovement of the connector 202 and the cannula 204. In the illustratedembodiment, the resistance element 240 comprises an O-ring 242 that isreceived within an annular channel 244 defined by the proximal segment222. The O-ring 242 can slide along an inner surface of the connector202. Any other suitable resistance mechanism is contemplated, such as asaw tooth, ratchet, or other interface between the proximal segment 222and the connector 202. In other or further embodiments, the resistanceelement 240 can include friction grease in addition to or instead ofother resistance elements that regulate relative movement of theconnector 202 and the cannula 204.

As previously discussed, in various embodiments, the connector 202 canbe configured to couple with an open catheter system and/or a closedcatheter system. In some embodiments, the connector 202 may be attacheddirectly to a catheter hub of an open catheter system, while in otherembodiments, the open catheter system can include an extension setattached to the catheter hub, and the connector 202 can be attached to aport of the extension set.

With reference again to FIG. 7, in some embodiments, the reinforcementmember 230 includes a protrusion or projection 213 that extends distallyfrom a surface 217 (e.g., a distally facing surface) of the connector202. The surface 217 may also be referred to as a bottom surface or as arecessed, inner, or internal surface of the connection region 203 of theconnector 202. The inner and internal surface descriptors arise from therecessed relationship of the surface 217 relative to adjacent portionsof the connector 202, such as relative to a threaded skirt 215 and acentral male luer, although the surface 217 is an overall exterior ofthe connector 202. In the illustrated embodiment, the projection 213includes the central male luer, which is formed of polymeric material,and within which a distal portion of the reinforcing tube 232 ispositioned. Stated otherwise, the projection 213 includes a distal endof the reinforcing tube 232 encompassed by other material (e.g.,polymeric material) that projects distally from the recessed surface217. In some embodiments, the projection 213 can be coupled directlywith an open hub (e.g., the catheter hub 106 in FIG. 1), such as toengage the hub in a fluid-tight seal (e.g., via luer interfaces). Theprojection 213 can be configured to open or otherwise defeat a valve,septum, or the like of a hub or of an extension set coupled to thecatheter hub 106, which can permit fluid communication between thecatheter tube 104 and the cannula 204. In the illustrated embodiment,the projection 213 extends distally from a bottom surface 217 of theconnection interface 211. The connection interface 211 further includesthe threaded skirt 215, which may comply with ISO standards for luerfittings. The skirt 215 may include a distal edge 219, which cancorrespond with a distalmost end or tip of the connector 202. In theillustrated embodiment, the projection 213 extends distally beyond thedistal edge 219 of the connector 202.

The coupling interface 210 of the connector 202 can be of any suitablevariety. For example, the coupling interface 210 can include threading225, such as for luer lock interfacing. Similar threading 525, 625 isdepicted in FIGS. 10 and 11. In other embodiments, the couplinginterface 210 can utilize friction fit or other mechanical engagement(e.g., snap fit). Illustrative examples of friction-fit interfaces areidentified as the features 328 and 428 in FIGS. 8 and 9, respectively.An illustrative snap-fit coupling interface is depicted, e.g., in FIG.32A, as further discussed below.

In various embodiments, the reinforcement member 230 and/or thereinforcing cannula 232 may be flush with the inner, recessed, bottom,or distal-facing surface 217 of the connector 202. For example, in theembodiment depicted in FIG. 8, a distal end of a reinforcing cannula 332is encompassed by or encased in a material that forms a connector 302.

In other embodiments, such as previously discussed, the reinforcementmember 230 and/or the reinforcing cannula 232 may project distally froma distally facing surface of the connector 202, such as from the inner,recessed, bottom, or distal-facing surface 217 of the coupling interface210. In this manner, the reinforcing reinforcement member 230 and/or thereinforcement cannula 232 can pierce or otherwise defeat valves, stops,etc. of a preplaced catheter system as the connector 202 is coupled tothe preplaced catheter system. For example, a catheter hub of apreplaced catheter system may include a septum or a valve that can bepierced, compressed, or otherwise opened by the reinforcement member230. For example, as previously discussed, the projection 213 of theembodiment depicted in FIG. 7, which includes a distal end of thereinforcement cannula 232 therein, may be configured to open or defeat avalved member of the preplaced catheter system—for example, may defeat avalve associated with the catheter hub 106 (see FIG. 1) in someinstances, and/or may defeat a valve associated with an extension set(see, e.g., FIG. 24) coupled with the catheter hub 106.

With reference to FIGS. 9 and 11, the distal end of reinforcementmembers 430, 630, which define projections 413, 613, may be formedsolely by distal ends of reinforcement cannulas 432, 632 that projectdistally from bottom, inner, recessed, or distally facing surfaces 417,617, respectively. Each reinforcement cannula 432, 632 can be insertedthrough a valve as its respective connector 402, 602 is coupled with apreplaced catheter system (whether directly to a catheter hub or to ahub of an extension set), in some instances. In other instances, asdiscussed below, the reinforcement cannulas 432, 632 can be dimensionedsuch that the distal tip of the reinforcement cannula 432, 632 isinstead positioned at, adjacent to, or slightly proximally recessed froma proximal surface of a valve member as the associated connector 402,602 is attached to a preplaced catheter system. As further discussedbelow, in certain of such embodiments, the respective cannula 404, 604can be advanced distally to pierce through the valve member while beingreinforced by the distal projection of the reinforcement cannula 432,632.

With reference again to FIGS. 5-7, in some embodiments, the cannula 204can be formed of fewer than three distinct pieces or fewer than threeseparate segments. For example, in some embodiments, the cannula 204 caninclude a distal segment 226, such as that previously disclosed, coupledto a rigid tube that extends proximally to the connector 229 (e.g., luerconnector) at a proximal end of the cannula 204. Stated otherwise, themedial segment 224 may be extended proximally so as to replace anelongated portion of the proximal segment 222. In some instances, therigid tube is a metallic tube, such as stainless steel. In furtherinstances, the rigid tube abuts a polymeric tube that forms the distalsegment 226, as previously discussed. For example, the polymeric tube ofthe distal segment 226 and the stainless steel tube of the medialsegment 224 can abut at an interface and be connected to each other viaheat shrink tubing.

In other instances having an elongated medial segment 226 in place ofthe proximal segment 222, a polymeric tube may extend continuously alongboth the distal and medial segments 226, 224. The rigid tube of themedial segment 224 may encompass that portion of the polymeric tube thatextends proximally from the distal segment 226. Stated otherwise, insome embodiments, a single polymeric tube (e.g., of polyimide) mayextend continuously from the distal tip 217 of the cannula 204 to theproximal connector 229. A second tube, such as the support tubepreviously described, can sheath a portion of the polymeric tube andextend from the interface 252 all the way proximally to the proximalconnector 229. Stated in yet another manner, the cannula 204 can include(1) a distal segment 226, formed solely of a polymeric tube extendingdistally from the interface 252 to the distal tip 217 of the cannula204, and (2) a medial segment 224, formed of a continuous proximalextension of the polymeric tube and a second rigid support tube thatsheaths or encompasses the proximal extension of the polymeric tube,with each of said continuous proximal extension of the polymeric tubeand the support tube extending proximally from the interface 252 andterminating at the proximal connector 229.

In still other embodiments, the rigid tube of the medial segment 224 maybe extended proximally through an interior of the proximal segment 222.Stated otherwise, the proximal segment 222 may include a diametricallylarger piece (e.g., of plastic) that encases a proximal portion of themedial segment 224. In some embodiments, the rigid cannula (e.g., whichmay be metallic) of the medial segment 224 may extend proximally to theconnector 229.

The proximal segment 222 has been described herein as a portion of thecannula 204. The elongated molded piece that forms the illustratedproximal segment 222 may alternatively be described as an elongatedproximal connector 229 (e.g., an elongated luer connector) that extendsdistally. That is, the proximal segment 222 may be viewed as a distalextension of the connector 229.

FIG. 8 depicts a distal portion of another embodiment of an accesssystem 300, which can resemble other access systems disclosed herein,such as, for example, the access system 200. Accordingly, features ofthe access system 300 are designated with reference numerals similar tothose of the access system 200, with the leading digit “2” beingreplaced with “3.” Relevant disclosure set forth above regardingsimilarly identified features thus may not be repeated hereafter.Moreover, specific features of the access system 300 may not be shown oridentified by a reference numeral in the drawings or specificallydiscussed in the written description that follows. However, suchfeatures may clearly be the same, or substantially the same, as featuresdepicted in other embodiments and/or described with respect to suchembodiments. Accordingly, the relevant descriptions of such featuresapply equally to the features of the access system 300. Any suitablecombination of the features and variations of the same described withrespect to the access system 200 can be employed with the access system300, and vice versa. Similarly, the access system 300 can suitably beused within the base catheter system 100 and other preplaced cathetersand catheter systems described herein. That is, disclosures regardingvarious access systems 300 can be appropriately applied to other accesssystems described herein, in the interest of streamlining the presentdiscussion. This pattern of disclosure applies equally to furtherembodiments depicted in the various figures and described herein,wherein the leading digits may be further altered.

As previously mentioned, the access system 300 includes a connectioninterface 310 that has a friction-fit arrangement, rather thanthreading. A distal tip of a reinforcement tube 332 is flush with aninner surface 317 of the connection interface 310.

In the illustrated embodiment, a cannula 304 is shown in a retractedorientation. In this orientation, a distal tip 327 of the cannula 304 isrecessed slightly from a distal tip of the reinforcement tube 332.

FIG. 9 depicts another embodiment of an access system 400 that includesa connector 402 having a connection interface 410 that likewise has afriction-fit arrangement. The projection 413 is defined by a distal endof a reinforcement tube 432 that extends distally from an inner orrecessed surface 417 of the connection interface 410. In the illustratedembodiment, a distal tip of the reinforcement tube 432 is proximallyrecessed relative to a distal edge 419 of the connector 402.

In the illustrated embodiment, when a movable cannula 404 is in aretracted position, a distal tip 427 of the cannula is substantiallyflush with a distal tip of the reinforcement tube 432. In this retractedorientation, the distal tip 427 of the cannula 404 is distally spacedfrom the inner or recessed surface 417 and is proximally spaced from thedistal edge 419 of the connector 402.

As previously discussed, FIGS. 10 and 11 depict additional embodimentsof access systems 500, 600 that resemble the access systems 300, 400,respectively. The access systems 500, 600 have connectors 502, 602having connection interfaces 510, 610 that include threading 525, 625.The access systems 500, 600 include reinforcement members 530, 630 thatinclude reinforcement tubes 532, 632.

In some embodiments, the access systems 300, 400, 500, 600 can beparticularly well suited for coupling with closed intravenous cathetersystems. As further discussed below, in some embodiments, thereinforcement tubes 332, 432, 532, 632 may be spaced from an outerseptum or cover of the closed IV catheter system. In other embodiments,the reinforcement tubes 332, 432, 532, 632 can be dimensioned to extendthrough the outer septum or cover of the closed IV catheter, but adistal tip thereof may (1) be at or proximally spaced from a proximalsurface of a valve (or plug or inner septum), (2) not extend through thevalve, and/or (3) not contact the valve, as discussed further below.

FIG. 12 is a perspective view of an embodiment of a closed cathetersystem 700, which may also be referred to herein as a closed basecatheter system 700. Any suitable closed catheter system iscontemplated, such as, for example, a closed intravenous cathetersystem. For example, the closed base catheter system 700 can compriseany of the NEXIVA™ lines of catheters (e.g., the DIFFUSICS™ line)available from Becton Dickinson. Certain of such closed catheter systemsmay have an extension set 802 integrated therein. For example, in theillustrated embodiment, a hub 806 of the extension set 802 includes aside port 813 with an extension tube 817, a connector 818, and aremovable vent fitting 819, similar to extension set arrangements thatmay be used with open intravenous catheter assemblies (e.g., such as theextension set depicted in and described with respect to FIG. 24). Thehub 806 may also be referred to as a catheter hub.

The closed catheter system 700 can include a removable needle assembly721 that includes a needle 720 connected to a needle hub 722. The needleassembly 721 can be coupled with the catheter hub 806 and used duringinsertion of a catheter tube 704 into the vasculature of a patient, andcan be removed from the catheter hub 806 thereafter. The needle 720 andits two-part hub 722 can be inserted into the catheter hub 806 and thecatheter tube 704 during assembly of the closed catheter system 700, andcan be packaged in such a preassembled configuration, such as thatdepicted in FIG. 12.

In FIG. 12, the catheter system 700 is shown in an insertionconfiguration. The needle 720 extends from a distal tip of the catheter704 to permit insertion of the catheter tube 704 into the vasculature ofa patient.

FIG. 13 is a perspective view of the closed catheter system 700 in adisassembled state, such as may be achieved after the catheter tube 704has been inserted into a blood vessel of a patient. The needle assembly721 is shown as having been removed from the hub 806 and catheter tube704. The illustrated configuration may be referred to as an accessconfiguration. For example, once the catheter tube 704 has beenpositioned within the vasculature of the patient in any suitable manner,including those presently employed, and once the needle assembly 721 hasbeen removed, access to the vasculature may be achieved via the placedcatheter tube 704. For example, the vent fitting 819 may be removed atany suitable stage, and a fluid source or fluid receptacle may becoupled with the connector 818 if the integrated extension set 802 toachieve fluid delivery to the vasculature and/or fluid removal from thevasculature via the catheter tube 704.

The needle 720 can be fixedly attached to the needle hub 722. In theillustrated embodiment, the needle hub 722 is a two-part hub thatprovides shielding capabilities to a distal tip of the needle 720 toavoid needle sticks when the needle 720 is withdrawn from the catheterhub 806 after the catheter tube 704 has been introduced into the vesselof the patient.

FIG. 14 is a cross-sectional view of the catheter hub 806 and thecatheter tube 704 of the closed catheter system 700 in an operationalstate in which the needle 720 has been fully removed from the cathetertube 704 and from the catheter hub 806. The catheter hub 806 can includea distal port 807 in fluid communication with the catheter tube 704, aproximal port 809 that is described below, and the side port 813 of theintegrated extension set 802, to which the extension tube 817 andconnector 818 (FIG. 12) are coupled. Each of the distal and side ports807, 813 is in continuous fluid communication with an inner chamber 810.

Certain embodiments of access systems (e.g., the access systems 300,400, 500, 600), or portions thereof, such as any suitable access system,or portion thereof, disclosed herein can be used with the closedcatheter system 700 while in the operational state—namely, the accessstate—depicted in FIG. 14, in which the needle assembly 721 has beenremoved. In certain embodiments, the access systems (e.g., 300, 400,500, 600) may not include their own extension sets (e.g., such as theextension set depicted in FIG. 24), as the catheter hub 806 of theclosed base catheter system 700 already includes an extension setintegrated therein. In some embodiments, the distal connectioninterfaces of the access systems 300, 400, 500, 600 depicted in, e.g.,FIGS. 8-11 may be particularly well-suited for interfacing with theclosed catheter system 700. For example, friction-fit or snap-fitconnectors may connect well with certain embodiments of the proximalport 809.

With continued reference to FIG. 14, the proximal port 809 can include aplurality of components coupled thereto or therein. In particular, theproximal port 809 can include an outer or proximal septum or cover 851,an inner or distal septum or plug 852, and a retainer 853. In variousembodiments, the septa 851, 852 may be formed of any suitableelastomeric materials. The retainer 853 may be formed of a relativelyrigid polymeric material and may interface with a polymeric housing ofwhich the catheter hub 806 is formed to retain the septa 851, 852 withinthe proximal port 809.

In typical or standard use of the closed catheter system 700, the needle720 (FIGS. 12 and 13) extends through the retainer 853 and the septa851, 852 of the proximal port 809, through the catheter hub 806, andthrough the catheter tube 704 when the closed catheter system 700 is inthe insertion configuration. The needle 720 may more generally bereferred to as a piercing member or as a piercing implement. Forexample, in other embodiments, the needle 720 may be replaced with anyother suitable piercing member or piercing element, such as, forexample, a trocar. The proximal port 809 may also be referred to as animplement port.

Upon placement of the catheter tube 704 within a vessel of the patient,the needle 720 is fully removed, thus placing the closed catheter system700 in the access state depicted in FIG. 14. As the needle 720 isremoved from the inner septum, distal septum, or plug 852, the plug 852self-seals to close off the proximal end of the inner chamber 810 andprevent fluid communication between the inner chamber 810 and theproximal port 809. In typical or standard use, the proximal port 809 isno longer used, and all further fluid communication with inner chamber810 and/or the catheter 704 is achieved vie the integrated extension set802, or stated otherwise, via the side port 813. The plug 852 is notused in any further access events, and desirably remains sealed for theremaining use of the closed catheter system 700.

As previously discussed, and as further discussed hereafter, certainembodiments of access systems are able to interface with the proximalport 809 in an atypical fashion by coupling with the proximal port 809and passing a cannula (e.g., 304, 404, 504, 604) through the plug 852and into the catheter tube 704. Through this process, the cannula (e.g.,304, 404, 504, 604) can, upon passing through the plug 852, achievefluid communication with the inner chamber 810 and/or the catheter tube704. Moreover, when the cannula (e.g., 304, 404, 504, 604) extendsthrough the plug 852, fluid is able to pass through the cannula, andhence is able to pass through the plug 852 and, more generally, throughthe proximal port 809. Moreover, in some instances, multiple accessevents through the plug 852 in this manner are possible. The plug 852can again self-seal upon removal of the cannula (e.g., 304, 404, 504,604). Accordingly, due to the ability to use the distal septum or plug852 to selectively achieve fluid communication between (1) the cathetertube 704 and/or the inner chamber 810 of the catheter hub 806 and (2) anexterior of the closed catheter system 700 via the proximal port 809,the distal septum or plug 852 may additionally or alternatively bereferred to herein as a valve or valve member 852. Further, the distalseptum, plug, valve, or valve member 852 may also or alternatively bereferred to as a seal or sealing member.

In view of the foregoing, the septa 851, 852 and the retainer 853 may bedescribed in additional or alternative terms. For example, it may besaid that the proximal port 809 includes a valve assembly 850 that canpermit selective fluid communication between the inner chamber 810 andthe proximal port 809. In some instances, the valve assembly 850 isconfigured to fluidically seal against the needle 720 when the needle120 is fully inserted therethrough, such as in the insertionconfiguration depicted in FIG. 12, and is configured to self-seal so asto prevent fluid from egressing from the inner chamber 810 and throughthe proximal port 809 upon removal of the needle 720 therefrom toachieve the access configuration depicted in FIG. 13.

With continued reference to FIG. 14, the valve assembly 850 of theproximal port 809 can include the proximal septum 851, the distal septum852, and the retention member or retainer 853. The retainer 853 cancomprise a generally tubular element that interfaces with a body of thecatheter hub 806 to retain the proximal and distal septa 851, 852 withinthe proximal port 809. That is, the retainer 853 may cooperate with ahousing portion of the hub 806 to hold the septa 851, 852 in placewithin the proximal port 809. Although the illustrated valve assembly850 includes multiple septa 851, 852, only the distal septum 852 mayprovide the valving functionality of the valve assembly 850 discussedabove, and further discussed below.

In some embodiments, the proximal septum 851, which is also oralternatively referred to as a cover, includes an opening 854, which maybe centered relative to the port 809. The opening 854 may be a permanentopening. When the closed catheter system 700 is in the insertion statedepicted in FIG. 12, the needle 720 can extend through the opening 854of the proximal septum 851. The opening 854 may be preformed and/or maybe sufficiently large such that the opening 854 does not self-seal uponremoval of the needle 720 therefrom.

The retainer 853 can include an opening 855, which can be larger thanthe opening 854 of the proximal septum 851. The opening 855 can beconcentric with the opening 854.

As previously noted, the valve 852 may be self-sealing, such that uponremoval of the needle 720 therefrom, a sealable region 856, which mayalso or alternatively be referred to as a “closable opening” (as opposedto the permanent opening 854 of the proximal septum 851), self-seals toprevent fluid communication between the chamber 810 and the port 809. Insome embodiments, a fluid-tight seal formed by the closable opening orsealable region 856 is sufficiently strong to withstand high pressures,such as may be achieved when power injection is performed via the sideport 813 to pass fluid through the inner chamber 810 and the distal port807.

In certain embodiments, when an access system (e.g., either accesssystem 400, 600) is coupled with the proximal port 809 of the closedcatheter system 700, a reinforcement member of the access system (e.g.,the reinforcement member 430, 630 of the access system 400, 600,respectively) can extend through the openings 855, 854 of the retainer853 and the proximal septum 851, respectively, and a distal tip of thereinforcement member (e.g., the distal tip of the reinforcement tube432, 632) may be positioned at or proximally recessed from a proximalsurface of the distal septum or valve 852. One such illustrativecoupling event and coupling configuration are depicted in FIGS. 33 and34, respectively, which is discussed further below. The distal tip ofthe reinforcement member (e.g., 430, 630) may be fixed in this positionrelative to the valve 852. The reinforcement member (e.g., 430, 630) canthereby align a movable/deployable cannula (e.g., 404, 604) of theaccess system with the valve 852. Stated otherwise, a longitudinal axisof the reinforcement tube (e.g., 432, 632) can be centered on andcolinear with a line that extends through the sealable region 856 of thevalve 852, which line corresponds to a sealed tract from which theneedle 720 has previously been removed (this may also be referred to asa needle tract through the sealable region 856). The reinforcementmember (e.g., the reinforcement tube) does not contact the valve 852 orextend into or through the valve 852. Rather, the cannula (e.g., 404,604) of the access system is extended out of the reinforcement member(e.g., the reinforcement tube 432, 632) and then through the sealableregion 856 of the valve 852.

In still other embodiments, when an access system (e.g., either accesssystem 300, 500) is coupled with the proximal port 809 of the closedcatheter system 700, a reinforcement member (e.g., 330, 530) of theaccess system (e.g., 300, 500) can remain external to, recessed from, orotherwise not extend through the openings 855, 854 of the retainer 853and the proximal septum 851, respectively. A distal tip of thereinforcement member (e.g., the distal tip of the reinforcement tube332, 532) may be proximally recessed from a proximal surface of thedistal septum or valve 852. Indeed, the distal tip of the reinforcementmember (e.g., the distal tip of the reinforcement tube 332, 532) maysufficiently recessed from the valve 852 so as to also be at orproximally recessed from a proximal surface of the cover or proximalseptum 851. The distal tip of the reinforcement member (e.g., 330, 530)may be fixed in this position relative to the valve 852. Thereinforcement member (e.g., 330, 530) can align a movable/deployablecannula (e.g., the cannula 304, 504) of the access system with alongitudinal axis of the valve 852. Stated otherwise, a longitudinalaxis of the reinforcement tube (e.g., 332, 532) can be centered on andcolinear with the line through the sealable region 856 of the valve 852that corresponds to a sealed tract from which the needle 720 haspreviously been removed (e.g., the needle tract through the sealedregion 856), as previously described. An imaginary extension of thisline in the proximal direction can extend through the openings 855, 854of the retainer 853 and the proximal septum 851, respectively, and bealigned with the longitudinal axis of the reinforcement tube. Thereinforcement member (e.g., 330, 530), or in certain embodiments, thereinforcement tube (e.g., 332, 532) does not contact the valve 852 orextend into or through the valve 852. Rather, the cannula (e.g., 304,504) of the access system is extended out of the reinforcement member(e.g., 330, 530), then through the proximal septum 851, and then throughthe sealable region 856 of the valve 852 along a substantiallyrectilinear path.

In certain embodiments, the distal end of the deployable cannula (e.g.,any of the cannulae 304, 404, 504, 604 of the access systems 300, 400,500, 600) can successfully be extended through the valve 852 withoutdamaging or kinking the cannula (e.g., 304, 404, 504, 604) and withoutdamaging the valve 852. In some instances, by avoiding contact of thereinforcing tube with the valve 852, or by not embedding the reinforcingtube within the valve 852, during an insertion or deployment event, thematerial of the valve 852 remains in a more relaxed state, or statedotherwise, is in a less compressed or less stressed state, or may be ina fully uncompressed or unstressed state, which can facilitate insertionof the movable cannula (e.g., 304, 404, 504, 604) therethrough.Moreover, as previously noted, in some instances coupling the accesssystem (e.g., 300, 400, 500, 600) with the proximal port 809 can centerthe reinforcement member (e.g., 330, 430, 530, 630) relative to thevalve 852 and thereby align the cannula (e.g., 304, 404, 504, 604) withthe valve 852, such that the cannula (e.g., 304, 404, 504, 604) can beinserted along the same path through the valve 852 or through the sameportion of the valve 852 from which the needle 720 has previously beenremoved (e.g., the needle tract through the sealable region 856), whichmay facilitate or enable insertion of the cannula (e.g., 304, 404, 504,604) through the valve 852. In certain embodiments, reinforcementfeatures as described elsewhere herein, can make such insertion of onlythe cannula (e.g., 304, 404, 504, 604) through the valve 852 possible.In some instances, if the cannula is not reinforced at more proximalregions thereof, the cannula may bend or kink upon contact with thevalve 852, which can prevent insertion of the cannula through the valve852.

In some instances, it may be advantageous to not insert a reinforcementtube (e.g., either reinforcement tube 432, 632 of the access systems400, 600) or any portion thereof into the valve 852 in order tothereafter advance the cannula (e.g., 404, 604) through reinforcementtube to thereby achieve passage of the cannula through the valve. Aspreviously noted, maintaining the reinforcement tube (e.g., 432, 632)external to the valve 852 (or proximally recessed from a proximalsurface of the valve 852) prior to and during insertion of the cannula(e.g., 404, 604) through the valve 852 can maintain the valve 852 in arelatively relaxed or uncompressed state, which can facilitate distalmovement of the cannula (e.g., 404, 604) through the valve 852. In otheror further instances, damage to the valve 852, such as coring of thevalve 852 by a distal tip of the reinforcement tube (e.g., 432, 632)and/or permanent stretching or deformation of the valve 852 by arelatively larger outer diameter of the reinforcement tube (e.g., 432,632), can be avoided.

Stated otherwise, as can be appreciated from the present disclosure, incertain instances, it can be advantageous to advance the cannula throughthe valve 852 without first inserting a separate supporting orreinforcing member into or through the valve 852 (e.g., a reinforcingmember of a larger diameter that could stretch out or deform the valve852 and/or of a variety which could undesirably core a portion of thevalve 852 upon passage therethrough). That is, it can be advantageous toadvance the cannula through the valve 852 independently, on its own, orwithout doing so through a separate member (e.g., reinforcement orsupport member) that has previously been advanced into or through thevalve and that remains positioned in or through the valve so as todefine an open channel (e.g., corresponding to the inner lumen of thesupport member) through at least a portion of the valve for subsequentpassage of the cannula.

In some instances, after an access system (e.g., 300, 400, 500, 600) hasbeen used with the closed catheter system 700 and removed therefrom, thevalve 852 can remain sealed during subsequent use of the integratedextension set 802. Stated otherwise, use of an access system (e.g., 300,400, 500, 600) with the closed catheter system 700 can have no adverseeffect on operation of the valve 852, or can preserve effective ornormal operation of the valve 852. Stated otherwise, use of the accesssystem with closed catheter system 700 can, upon removal of the accesssystem, permit the inner septum 852 to once again plug or seal theproximal port 809. For example, in some instances, after removal of adeployable cannula (e.g., 304, 404, 504, 604) from the catheter tube 704and from the distal valve 852 of the closed catheter system 700 afteruse of an access system (e.g., 300, 400, 500, 600) therewith, theintegrated extension set 802 of the closed catheter system 700 can beused to access the vasculature of the patient (e.g., for an infusion oraspiration event) via the placed catheter tube 704 in the same manner asmay have been accomplished prior to use of the access system (e.g., 300,400, 500, 600) with the closed catheter system 700. In some instances,the valve 852 remains sufficiently strong and fluid-tight to permit useof the closed catheter system 700 for power injections through the sideport 813 after removal of the access system (e.g., 300, 400, 500, 600).In certain embodiments, use of an access system (e.g., 300, 400, 500,600) with the closed catheter system 700 has no adverse effect on thevalve 852, such that after 1, 2, 3, 4, 5, 10, 15, 20, or 25 or morecoupling and decoupling cycles of one or more access assemblies (e.g.,300, 400, 500, 600) with and from a closed catheter system 700, thevalve 852 of the closed catheter system 700 continues to operate in itsoriginal manner. For example, the valve 852 can continue to maintain afluid-tight seal during a power injection through the closed cathetersystem 700 after one or multiple coupling/decoupling event or events.

FIG. 15 is a perspective view of another embodiment of an access system1000 configured to be coupled with embodiments of a base cathetersystem. For example, in some embodiments, the access system 1000 isconfigured to be coupled with an open base catheter system, whetherdirectly (e.g., by direct attachment to a catheter hub) and/orindirectly (e.g., by direct attachment to a proximal port of anextension set that is attached to a catheter hub), as further discussedbelow. The access system 1000 is shown in a fully retracted orundeployed state.

In the illustrated embodiment, the access system 1000 includes aconnector 1002 and a cannula 1004 that is selectively advanceable andretractable relative to the connector 1002. As with other embodimentsdescribed herein, the cannula 1004 can include a connector 1029 at aproximal end thereof. In the illustrated embodiment, the connector 1029is a female luer.

The connector 1002 can include a connection interface 1010 and areinforcement member 1030. In the illustrated embodiment, thereinforcement member 1030 includes a distal projection 1013 that extendsa significant distance past a distal face of the connection interface1010. The distal projection 1013 may be narrower and more elongated thana luer interface, in some instances.

With reference to FIG. 16, in some embodiments, the access system 1000includes an internal stop, hub, or follower 1060, to which a proximalsegment 1022 of the cannula 1004 is attached. The follower 1060 can besized to prevent the cannula 1004 from being retracted fully from asheath 1005. Stated otherwise, a proximal end of the sheath 1005 and thefollower 1060 can cooperate to delimit proximal movement of the cannula1004. The follower 1060 can have a greater radial dimension than anopening 1061 at a proximal end of the sheath 1005. In variousembodiments, the follower 1060 can be fixedly secured to one or morecomponents of the cannula 1004 (e.g., the proximal segment 1022 and/or amedial segment 1024) and can move in response to movement of the cannula1004. Stated otherwise, the follower 1060 can move in unison with thecannula 1004 and in response to forces imparted to the cannula 1004. Inparticular, the follower 1060 is not directly accessible by a user, andinstead moves solely in response to forces applied to the proximalsegment 1022 of the cannula 1004 by a user at an exterior of the sheath1005.

In certain embodiments, the follower 1060 can restrict, inhibit, orprevent rotational movement of the cannula 1004 relative to the sheath1005 about a longitudinal axis, which these components may have incommon. Stated otherwise, the follower 1060 can cooperate with thesheath 1005 to rotationally lock the cannula 1004 relative to the sheath1005, thus preventing relative rotation of these components about acentral longitudinal axis about which the components are concentricallyarranged. For example, in the illustrated embodiment, the follower 1060includes a protrusion 1062 that fits within a longitudinal groove 1064defined by the sheath 1005. In other embodiments, the groove/protrusioninterface may be reversed. For example, in some embodiments, thefollower 1060 defines a groove that receives a longitudinal protrusionthat extends inwardly from the sheath 1005. The protrusion 1062 and thegroove 1064 may be referred to as a rotational alignment mechanism 1065or as a rotational lock. Any suitable rotational alignment mechanism iscontemplated.

Other embodiments may permit free rotation between the cannula 1004 andthe sheath 1005. For example, some embodiments may be devoid of arotational alignment mechanism. For example, in some embodiments, aninterior surface of the sheath 1005 and an exterior surface of thefollower 1060 each may be substantially cylindrical so as to readilypermit relative rotation.

FIG. 17A is a perspective view of the housing 1005, and FIGS. 17B and17C are separate cross-sectional views of the housing 1005. The groove1064, which may also be referred to as an internal track, is visible ineach view. With reference to FIG. 17A, in some embodiments, the housing1005 includes one or more gripping features 1068. The gripping features1068 can include one or more of grooves, coverings, coatings, and/orother surface features to enhance grippability, ergonomics, and/ormanipulation of the housing 1005. The gripping features 1068 of theillustrated embodiment includes grooves and a high friction layer ofmaterial. The gripping features 1068 further include a pair ofdiametrically opposite raised wings 1069 at a distal end of the housing1005. The wings 1069 may, in some instances, assist in manipulation ofthe housing 1005 to rotate the housing 1005 for coupling with the accesssystem 1000 with a connector of a catheter hub or an extension set hub.

FIGS. 18A and 18B depict an embodiment of a coupling member 1070 thatmay be attached to a distal end of the housing 1005, and may form adistal end of the connector 1002. The coupling member 1070 can includeany suitable connection interface 1010, such as those previouslydiscussed. In the illustrated embodiment, the connection interface 1010includes internal threading, such as may be used, for example, to couplewith a threaded luer interface.

The coupling member 1070 can define a reinforcing member 1030. As withother embodiments previously discussed, the reinforcing member 1030 caninclude a distal projection 1013 that extends distally from a bottom,inner, or recessed surface 1017 of the connection interface 1010. In theillustrated embodiment, the distal projection 1013 is formed of twodifferent components. In particular, an outer layer of the distalprojection 1013 is formed of a polymeric material, and constitutes anextension of a continuous casting or molding of polymeric material ofwhich much of the reinforcing member 1030 is formed. The distalprojection 1030 further includes at least a distal end of an internallysituated reinforcing tube 1032, such as reinforcing tubes previouslydescribed. The reinforcing tube 1032 is embedded within the couplingmember 1070. In some embodiments, the polymeric portion of the couplingmember 1070 is overmolded onto the reinforcing tube 1032.

The reinforcing member 1030 can further include an elongated proximalprojection 1031 of the polymeric material. The proximal projection 1031can extend proximally into an internal cavity of the sheath 1005 whenthe coupling member 1070 is secured to the sheath 1005, as shown in FIG.16. A lumen 1033 can extend continuously through the proximal projection1031 and through the reinforcing tube 1032. In some embodiments, aninternal diameter of the lumen 1033 is substantially constant along afull length of the reinforcing member 1030, or stated otherwise, along afull length of the lumen 1033 that extends from a proximal tip of theproximal projection 1031 to a distal tip of the reinforcing tube 1032.

In other embodiments, the proximal projection 1031 may be omitted, andthe reinforcing tube 1032 can be extended proximally, similar to anarrangement such as that depicted in FIG. 7.

FIGS. 19A and 19B are perspective views of the follower 1060, and FIG.19C is a cross-sectional view of the follower 1060. The longitudinallyextending protrusion 1062 is shown in each view. The follower 1060defines a proximal cavity 1071 sized to receive a distal end of theproximal segment 1022 of the cannula 1004 therein. In some embodiments,the distal end of the proximal segment 122 is adhered to the follower1060 (see FIG. 23A). The follower 1060 can further define a distalcavity 1072 that is enlarged relative to an outer diameter of the medialsegment 1024 of the cannula 1004, such that the medial segment 1024 canreadily pass through the distal cavity 1072 (see FIG. 23A). The follower1060 can include an opening 1073 through a sidewall 1074, which sidewall1074 separates the proximal and distal cavities 1071, 1072 from eachother.

With simultaneous reference to FIGS. 19A, 19B, and 23A, the opening 1073can be sized to permit passage therethrough of the medial segment 1024of the cannula 1004. A proximal end of a tube that forms at least aportion of the medial segment 1024 can extend through the opening 1073and be embedded in a distal end of the tube that forms at least aportion of the proximal segment 1022 of the cannula 1004, as shown inFIG. 23A. In some embodiments, these tubes may be adhered to oneanother. In certain illustrative manufacturing processes, the tubes ofthe cannula 1004 may be attached to one another and then passed distallythrough the opening 1073, at which point the distal end of the proximaltube can be adhered to the follower 1060 within the cavity 1071.

FIG. 20 is a cross-sectional view of an embodiment of the connector1029. In the illustrated embodiment, the connector 1029 includes afemale luer interface 1074. The connector 1029 further defines a cavity1076 sized to receive a proximal end of the proximal segment 1022 of thecannula 1004 therein (see, e.g., FIG. 16).

FIG. 21 is a partially exploded elevation view of the cannula 1004showing a tie layer 1080 separated from a distal tube 1081 and a medialtube 1082. In the illustrated embodiment, the distal tube 1081 isincluded in the distal segment 1026 of the cannula 1004 and the medialtube 1082 is included in the medial segment 1024 of the cannula 1004.The distal tube 1081 can be of any suitable material for the distalsegment 1026, such as those previously described. For example, in someembodiments, the distal tube 1081 is formed of polyimide. The medialtube 1082 likewise may be formed of any suitable material for the medialsegment 1024. For example, in some embodiments, the medial tube 1082comprises a stainless steel tube.

The tie layer 1080 can be used to join the tubes 1081, 1082 together.For example, as discussed previously, in some embodiments, the tie layer1080 can comprise a thin-walled tube of heat shrink material that isadvanced over at least a proximal end of the distal tube 1081 and adistal end of the medial tube 1082. The heat shrink tube can then beheated to securely attach to the ends of the tubes 1081, 1082 together.As with other embodiments discussed herein, in various embodiments, thedistal tube 1081 comprises a polymeric material and the medial tube 1082comprises a metallic material. The tie layer 1080 can comprise anysuitable material. For example, in various embodiments, the tie layer1080 includes a tube of heat-shrinkable polyethylene terephthalate(PET).

FIG. 22 is an enlarged cross-sectional view of the cannula 1004 with thetie layer 1080 in place over the tubes 1081, 1082. In the illustratedembodiment, the adjoined ends of the tubes 1081, 1082 abut one another.In particular, in the illustrated embodiment, each tube 1081, 1082 endhas a substantially flat or planar surface that is transverse to alongitudinal axis of the cannula 1004. These transverse surfaces abutone another to provide a surface of continuous contact. In someinstances, abutment along a plane that is perpendicular to alongitudinal axis through the tubes 1081, 1082 can inhibit bending atthat junction of the tubes 1081, 1082. For example, by maintaining tightcontact at the abutting faces, the tubes 1081, 1082 may be less inclinedto bend or kink at the junction, as compared, for example, tocircumstances in which space may be provided between the adjacent tubeends. Consistent with other disclosures herein, the tubes 1081, 1082 maybe said to abut one another at an interface 1052 of the cannula 1004.The distal end of the medial tube 1082 represents a distal terminus 1050of the medial member 1024.

In the illustrated embodiment, the inner diameters of the tubes 1081,1082 are substantially identical, such that a lumen 1021 of the cannula1004 is substantially smooth along at a transition from the distal tube1081 to the medial tube 1082. In some instances, a smooth transition caninhibit or prevent hemolysis of blood due to its passage through theinterface 1052.

In some embodiments, a distal tip of the tie layer 1080 can beproximally spaced from the distal tip of the cannula 1004. Such anarrangement may permit the distal tip of the tie layer to contact aninternal surface of the catheter tube 104 at a distal tip of thecatheter tube 104 to delimit proximal movement of the cannula 1004relative to the catheter tube 104. This may be an effective manner forlimiting an amount of the cannula 1004 that can extend past the distalend of the catheter tube 104. In some instances, contact between thedistal end of the tie layer 1080 and a narrowed inner surface of thecatheter tube 104 at the distal tip of the catheter tube 104 can providetactile feedback to a user regarding a position of the cannula 1004relative to the catheter tube 104, and in particular, to alert the userthat the cannula 1004 has been fully deployed.

FIG. 23A is a cross-sectional view of a generally proximal portion ofthe access system 1000 when the access system 1000 is in a retractedstate, or stated otherwise, when the cannula 1004 of the access system1000 is in a retracted state. As shown, the follower 1060 may besubstantially at a proximal end of the sheath 1005 when the cannula 1004is in the retracted state.

FIG. 23B is a cross-sectional view of a distal portion of the accesssystem 1000 in the retracted state. In this state, similar to previouslydescribed embodiments, the interface 1052 of the cannula 1004 can bepositioned within the reinforcement member 1030. Stated otherwise, anentirety of a proximal end of the distal segment 1026 of the cannula1004, including a proximal tip of the distal segment 1026, and thedistal terminus 1050 of the medial segment 1024 each can be positionedwithin the reinforcement member 1030 when the cannula 1004 is in theretracted state. In the illustrated embodiment, the interface 1052 ispositioned within the proximal extension 1031 of the reinforcementmember 1030 in this operational state.

In the illustrated embodiment, the distal tube 1081 has a distal tipthat is slightly recessed relative to a distal tip of the reinforcementtube 1032 of the reinforcement member 1030. In the illustratedembodiment, an entirety of the distal tube 1081 is positioned within thereinforcement member 1030. A distal end of the distal tube 1081 iswithin the reinforcement tube 1032 of the reinforcement member 1030,while a proximal end of the distal tube 1081 is within the proximalextension 1031 of the reinforcement member 1030. As with otherembodiments discussed herein, the reinforcement member 1030 can preventthe distal tube 1081 from bending or kinking during an insertion event,due to the reinforcement provided by the relatively close fit betweenthe inner diameter of the reinforcement member 1030 and the outerdiameter of the distal tube 1081.

FIG. 24 is an exploded perspective view of an embodiment of a basecatheter assembly 1100 that includes an embodiment of an openintravenous catheter assembly 1101 and an embodiment of an extension set1150 that is couplable to the open intravenous catheter assembly 1101.The catheter assembly 1101 includes a catheter hub 1106 and a cathetertube 1104, which can resemble the catheter hub 106 and the catheter tube104 described previously.

The extension set 1150 includes an extension hub 1180 that includes adistal port 1181, a side port 1182, and a proximal port 1183. The distalport 1181 can include a connector 1151 of any suitable varietyconfigured to couple with the catheter hub 1106. In the illustratedembodiment, the connector 1151 comprises a rotatable luer lock connectorfor selective engagement of a male luer 1171 with the catheter hub 1106.The side port 1182 includes an extension tube 1157 coupled thereto. Aconnector 1158 is attached to an opposite end of the extension tube1157. The proximal port 1183 can include a connector 1162, to which aconnection interface of any suitable access system (e.g., 200, 300, 400,500, 600, 1000) can be attached. In some embodiments, a valve 1184,which may also or alternatively be referred to as a septum, seal, etc.,may be included within the proximal port 1183. In some instances, theprojection 1013 of the access system 1000 can be capable of extendingthrough the valve 1184, and the cannula 1004 can be deployed, advanced,or extended distally from the distal end of the projection 1013 at aposition distal of the valve 1184.

Each of the distal port 1181, the side port 1182, and the proximal port1183 can be in fluid communication with an inner chamber 1173 (see FIG.25) defined by the extension hub 1180. As noted, in some embodiments,the proximal port 1183 may permit selective fluid communication with theinner chamber 1173 via the valve 1184.

FIG. 25 is a cross-sectional view of the base catheter assembly 1100 inan assembled state. The cross-sectional view is taken such that the sideport 1182 is not shown. The male luer 1171 can be inserted into andfluidically sealed with the female luer of the catheter hub 1106. Themale luer 1171 can have an elongated lumen 1172 at an interior thereof,which corresponds with a distal end of the inner chamber 1173. The lumen1172 can be a necked down or narrowed section of the inner chamber 1173.In general, when the access system 1000 is coupled with the extensionset 1150, rather than directly with the catheter hub 1106 of thecatheter assembly 1101, the cannula 1004 travels through a greaterdistance before entering the catheter tube 1104. Stated otherwise, thecatheter hub 1106 provides a first unsupported length between a distaltip of the access system 1000 and a proximal end of the catheter tube1104 when the access system 1000 is coupled directly to the catheter hub1106, whereas the catheter hub 1106 and the extension hub 1180, whencoupled together, provide a second unsupported length between the distaltip of the access system 1000 and the proximal end of the catheter tube1104, when the access system 1000 is directly coupled, to the extensionhub 1180, and the second unsupported length is significantly greaterthan the first unsupported length.

FIG. 26 is a side elevation view of the access system 1000 in theretracted state coupled with the assembled base catheter assembly 1100,which includes the extension set 1150 that has the side port 1182. FIG.27 is a cross-sectional view of a distal portion of the access system1000 in the retracted state while coupled with the assembled basecatheter assembly 1100. As with FIG. 25, the cross-sectional view istaken such that the side port 1182 of the extension set 1150 is notshown.

With the connector 1002 of the access system 1000 coupled with theconnector 1162 of the extension set 1150, the distal projection 1013 ofthe reinforcement member 1030 extends into the inner chamber 1173 of theextension hub 1180. In the illustrated embodiment, the distal tip of thedistal projection 1013 is positioned within a proximal end of thenarrowed lumen 1172 of the male luer 1171. The distal tip of theprojection 1013 is proximally spaced from a proximal tip 1107 orproximal edge of the catheter hub 1106. Accordingly, as previouslydiscussed, the cannula 1004 has a greater distance to travel through theextension hub 1180 and the catheter hub 1106 in order to enter theproximal end of the catheter tube 1104 than is needed when an accesssystem 1000 is coupled directly to a catheter hub 1106. In someembodiments, the distal projection 1013 may be longer and/or narrowerfor access assemblies that are intended for use with extension sets thanare those intended for use directly with catheter hubs 1106. Moreover,in the illustrated embodiment, a distal end of the distal projection1013 is advanced into the narrowed lumen 1172 of the male luer 1171.Correspondingly, in some embodiments, the distal projection 1013 may belonger than and/or narrower than a standard male luer.

FIG. 28 is a cross-sectional view of the access system 1000 in a fullydeployed state while coupled with the assembled base catheter assembly1100. FIGS. 29A-29C are close-up cross-sectional views of variousportions of the access system 1000 and the base catheter assembly 1100in this operational configuration. In particular, FIG. 29A depicts agenerally intermediate portion of the access system 1000, FIG. 29Bdepicts a generally distal portion of the access system 1000 and aproximal portion of the base catheter assembly 1100, and FIG. 29Cdepicts the distal ends of the access system 1000 and the base catheterassembly 1100.

As shown in FIG. 29A, in some embodiments, the proximal extension 1031of the reinforcement member 1030 can delimit distal movement of thecannula 1004. As previously discussed, the proximal segment 1022 of thecannula 1004 may be fixedly secured to the follower 1060. The distalcavity 1072 of the follower 1060 can have a sufficiently large innerdiameter to receive a proximal end of the proximal extension 1031 of thereinforcement member 1030 therein. As the cannula 1004 is advanceddistally, the distal cavity 1072 of the follower 1060 advances over theproximal end of the proximal extension 1031 until contact is madebetween the sidewall 1074 of the follower 1060 and the proximalextension 1031. This contact can prevent further distal advancement ofthe cannula 1004.

With reference to FIG. 29B, in the illustrated embodiment, when thecannula 1004 is in the fully deployed position, the distal segment 1026extends into and through the catheter tube 1104. In particular, as shownin FIG. 29C, in the illustrated embodiment, the distal segment 1026 ofthe cannula 1004 extends a significant distance beyond a distal tip 1109of the catheter tube 1104. In various embodiments, the distal segment1026 may extend distally beyond the distal tip of the catheter tube 1104by a distance that is no less than 3, 5, 10, or 15 times greater than anouter diameter of the distal segment 1026.

With reference again to FIG. 29B, when the cannula 1004 is in the fullydeployed position, the interface 1052 at which the distal and medialsegments 1026, 1024 meet may be positioned proximally relative to theproximal tip 1107 of the catheter tube 1104. Stated otherwise, thedistal terminus 1050 of the medial segment 1024 may remain external tothe catheter tube 1104, while being positioned distal of the reinforcingmember 1030. In some instances, the intrinsic support orself-reinforcing properties of the medial segment 1024 can inhibitkinking or buckling of the cannula within the elongated, generallyunsupported region of the inner chamber 1173 of the extension hub 1180and the internal chamber of the catheter hub 1106 as the cannula 1004 isadvanced distally.

In other embodiments, the medial segment 1024 may enter, and further,may pass through at least a proximal portion of the catheter tube 1104.For example, as previously described, in some embodiments, the distaland medial segments 1026, 1024 may have substantially the same outerdiameter dimensions, such that the medial segment 1024 could readilyfollow the distal segment 1026 into the catheter tube 1104.

Relative lengths of, e.g., the reinforcement member 1030 (e.g., theproximal projection 1031 thereof) and the cannula 1004—particularly theoverall length of the reinforcement member 1030 and a length of theportion of the cannula 1004 that is inserted through extension set 1150and into and through the catheter tube 1104—can be adjusted to ensurethat a distal tip of the cannula 1004 reaches a desired positionrelative to the distal tip of the catheter tube 1104 when the cannula1004 is in the fully deployed state. For example, as previouslydiscussed, in various embodiments, a distal tip of the cannula 1004 maydesirably extend distally beyond, may be substantially flush with, ormay be slightly proximally recessed relative to the distal tip of thecatheter tube 1104 when the cannula 1004 is in the fully deployed state.

Relative lengths of, e.g., the reinforcement member 1030 (e.g. theproximal extension 1031 thereof) and the medial segment 1024 can beadjusted to ensure that a distal tip of the medial segment 1024 reachesa desired position relative to the proximal end of the catheter tube1104 when the cannula 1004 is in the fully deployed state. For example,as previously discussed, in various embodiments, a distal tip or distalterminus 1050 of the medial segment 1024 may remain proximally recessed,may be substantially flush with, or may enter into the proximal end ofthe catheter tube 1104 when the cannula 1004 is in the fully deployedstate.

In other embodiments, the medial segment 1024 may include an outer tube,or support tube (e.g., such as the support tube 1495 depicted in FIGS.56A and 56B and described below). In some embodiments, at least an outerdiameter of the support tube may be larger than an opening at theproximal end of the catheter tube 1104 (e.g., which correspond to aninner diameter of the catheter tube 1104). The distal tip of the supporttube, which corresponds to the distal terminus 1050 of the medialsegment 1024, can prevent the medial segment 1024 from entering into thecatheter tube 1104. In some embodiments, use of a larger diametersupport tube as just described can advantageously act as a primarydefense against entry of the support tube into the catheter tube 1104.In other embodiments, this can act as a failsafe to ensure that thedistal tip of the support tube does not enter the catheter tube 1104,such as, for example, where other dimensions of the access assembly 1000also have been selected to prevent the support tube from entering thecatheter tube 1104. For example, in some embodiments, it may bedesirable to avoid entry of the distal tip of the support tube, whichotherwise could, in some arrangements, potentially deform, scrape, mar,and/or damage the catheter tube 1104 if permitted to enter therein. Inother embodiments, the support tube may be sufficiently narrow to enterthe catheter tube 1104.

With continued reference to FIG. 29B, as previously discussed, there maybe a significant distance between the distal tip of the reinforcementmember 1030 and the proximal end of the catheter tube 1104 when theextension set 1150 is present. In some instances, the self-reinforcedmedial segment 1024 can be sufficiently strong and/or rigid to avoidbending, kinking, or buckling within the unfilled portion of the cavity1173 of the extension hub 1180 and the adjoining unfilled cavity of thecatheter hub 1106 as the cannula 1004 is distally advanced through thisenlarged cavity region (i.e., enlarged as compared with the constrictionprovided by the reinforcement member 1030). In other or furtherinstances, the self-reinforced medial segment 1024 can maintainalignment of the distal segment 1026 with a longitudinal axis of thecatheter tube 1104 as the cannula 1004 is advanced distally. In other orfurther instances, the self-reinforced medial segment 1024 can reduce anunsupported length of the cannula 1004 within the extension hub 1180 andfurther, in some instances and/or in later stages of deployment, withinthe catheter hub 1106 as the cannula 1004 is advanced distally to thefully deployed state.

In some instances, the cannula 1004 may not be moved to a fully deployedstate. For example, in some instances, the cannula 1104 may only beadvanced from the initial or retracted position to a partially advancedposition. This partially deployed, partially advanced, or intermediatestate may be sufficient to achieve a desired position of the distal tipof the cannula 1004 beyond or within the distal end of the catheter tube1104. For example, in some embodiment, the access system 1000 may beusable with a variety of different base catheter systems that may havevarying lengths of catheter tubes 1104, and the user may deploy thecannula 1004 by a different amount depending on which length of cathetertube is present.

FIG. 30 is a perspective view of another embodiment of an access system1200 configured to be coupled with embodiments of a base cathetersystem, with the access system 1200 being shown in a retracted orundeployed state. The access system 1200 may be particularly well-suitedfor use with a closed intravenous catheter system, such as, for example,a NEXIVA™ closed catheter system. Embodiments of the access system 1200may resemble, e.g., embodiments of the access systems 300, 400, 500, 600described above. Relevant disclosures regarding the various accesssystems 300, 400, 500, 600, 1200 thus may be applied interchangeably.

For example, the access system 1200 can include a cannula 1204 of anysuitable variety, including those disclosed elsewhere herein. In someembodiments, the cannula 1204 can be of any of the varieties discussedabove, such as, for example, with respect to the cannulas 204, 1004, orbelow, such as, for example, with respect to the cannula 1404.

In the illustrated embodiment, the access system 1200 includes aconnector 1202 that is configured to couple with the proximal port 809of embodiments of a closed intravenous catheter system 700 (see, e.g.,FIGS. 14 and 34). For example, the distal end of the connector 1202, caninclude a snapping or snap-fit arrangement. In the illustratedembodiment, the connector end 1202 includes a pair of opposing arms orflaps 1280 with inward protrusions 1281 to securely snap onto theproximal port 809, as shown in FIG. 32A (see also FIGS. 33 and 34).

FIG. 31 is a cross-sectional view of the access system 1200 in theretracted state. FIG. 32A is a perspective view of an embodiment of acoupling member 1270 that is compatible with the access system 1200.FIG. 32B is a cross-sectional view of the coupling member 1270. Thecoupling member 1270 includes a reinforcing tube 1232 that extends orprojects distally relative to a bottom, inner, recessed, or distallyfacing surface 1217 of the connector 1202, in manners such as previouslydiscussed.

In other embodiments, the proximal projection 1231 may instead bedefined solely by a proximal extension of the reinforcing tube 1232,similar to an arrangement such as that depicted in FIG. 7. Statedotherwise, the reinforcing tube 1232 may define both a distal projection1213 and the proximal extension 1231.

FIG. 33 is a cross-sectional view of a distal end of the access system1200, while in the retracted or undeployed state, being advanced towardan embodiment of a closed intravenous catheter system 700 for couplingtherewith. FIG. 34 is a cross-sectional view of the distal end of theaccess system 1200, while in the retracted or undeployed state, coupledwith the closed intravenous catheter system 700. In the illustratedembodiment, a distal tip of the reinforcing tube 1232 is advancedthrough the proximal septum 851, but is proximally spaced from the valve852 when the access system 1200 and the closed catheter system 700 arecoupled together. Advancement of a cannula portion of the access system1200 through the reinforcing tube 1232, the valve 852, and ultimatelythe catheter tube 704 can proceed in manners such as previouslydiscussed.

For example, in the illustrated embodiment, the reinforcing tube 1232 isadvanced distally through the opening 855 of the retainer 853, thenthrough the opening 854 of the proximal septum 851. These openings 855,854 are aligned, or are colinear with, the sealable region 856 (and moreparticularly, the substantially linear needle tract through the sealableregion 856). In the illustrated embodiment, once the access system 1200is fully coupled to the proximal port 809 of the closed intravenouscatheter system 700, the distal tip of the reinforcing tube 1232 ispositioned at an interior of the proximal septum 851, as shown in FIG.34. After such coupling, the cannula 1204 can be advanced distally, andthe distal tip of the cannula 1204 can emerge from the reinforcing tube1232 to move substantially rectilinearly through the distal end of theproximal septum 851, then through the valve 852 (including through thesealable region 856 of the valve 856), then through the hub 806, theninto and through the catheter tube 704. As discussed elsewhere, thesupport member 1230 and/or the intrinsic support provided by the medialsegment of the cannula 1204 can assist in the successful insertion ofthe cannula 1204 through the valve 852 without kinking or buckling ofthe distal segment of the cannula 1204.

In some instances, once the distal tip of the cannula 1204 has passedthrough the sealable region 856 of the valve 852, the valve 852 maysupport the cannula 1204 as it is further advanced distally through thehub 806 and the catheter tube 704. For example, the valve 852 canprovide lateral support that inhibits lateral deflections of the cannula1204 in the region of contact between the sealable region 856 and thecannula 1204.

With continued reference to FIG. 34, as previously noted, in variousembodiments, the cannula 1204 may resemble any of the disclosedvarieties of the cannulas 204, 1004, or 1404 (which is described below).For example, in some embodiments, the cannula 1204 includes a distalsegment and a medial segment that resemble any variety of the distal andmedial segments 226, 224 and/or 1026, 1024, respectively, discussedabove, and/or the distal and medial segments 1426, 1424, respectively,discussed below. While only the distal segment is shown in FIG. 34, thepresence and structure of medial segment can be understood from otherdrawings and disclosures herein.

In some embodiments, the medial segment of the cannula 1204 includes twoabutting tubes that are joined by heat-shrink tubing (see, e.g., FIG.22). The medial tube can be rigid, and may be formed of a metal—forexample, the medial tube may comprise a stainless steel hypotube. Inother embodiments, the medial segment of the cannula 1204 includes aflexible central tube that extends continuously along the distal andmedial segments, but that is encompassed by a rigid tube along thelength of the medial segment (see, e.g., FIGS. 56A and 56B). The rigidtube may be formed of metal, such as a stainless steel hypotube. Ineither instance, the medial segment can have substantial radial strengthso as to resist radial compression that might otherwise constrict orclose a lumen through the tube. For example, in various embodiments, dueto the presence of a rigid tube in the medial segment, the medialsegment can have a greater ability to maintain a fluid path that extendsthrough a center of the medial segment in an open state, even underradial forces or stresses on the medial segment that would tend toconstrict or close the fluid path if left unopposed.

In certain embodiments of the access system 1200, when the cannula 1204is in the deployed state, the medial segment of the cannula 1204 fullyextends through the valve 852 of the closed intravenous catheter system700. For example, in some embodiments, either the rigid tube that formsthe medial segment or the support cannula that encompasses a flexibleinner tube along the length of the medial segment passes through thevalve 852 near the end of advancement of the cannula 1204 through thecatheter tube 704. Due to the intrinsic rigidity of the rigid tube ofthe medial segment, the medial segment can prevent inward stressesprovided to the cannula 1204 by the valve 852 that result from expansionof the sealable opening 856 from collapsing the medial segment. Forexample, in certain embodiments that include a flexible central tubepositioned within a rigid tube, the rigid tube can resist thecompressive forces from the valve 852 to maintain the inner tube in apatent state. Stated otherwise, upon final advancement of the cannula1204, or when a user is ready to aspirate or draw blood through thecannula 1204, the medial segment of the cannula 1204 can extendthroughout an entirety of the sealable region 856 of the valve 852 toprevent the valve 852 from collapsing a flow path through the cannula1204.

In various embodiments, an outer diameter of the medial segment of thecannula 1204 is the same as or only slightly larger than an outerdiameter of the distal segment. For example, in various embodiments, theouter diameter of the medial segment is no greater than 5, 10, or 15percent larger than the outer diameter of the distal segment. In someembodiments, a medial segment having a diameter that is the same or onlyslightly larger than the outer diameter of the distal segment mayreadily follow the distal segment through the valve 852 as the cannula1204 is advanced distally and/or may pass through the valve 852 withoutcausing damage thereto. In other or further embodiments, by virtue offollowing the distal segment into and through the valve 852, the medialsegment may readily pass through the valve 852 and/or may do so withoutdamaging the valve 852.

Reference is now made to FIGS. 35-53, which are directed to anotherembodiment of an access system 1300 that may be particularly useful withopen base catheter systems. For example, in some instances, the accesssystem 1300 may be particularly well suited for use with open basecatheter systems that include an extension set coupled with a catheterassembly, such as the open base catheter system 1100 depicted in FIGS.24 and 25. As previously discussed with respect to FIGS. 24-27 and 29B,the catheter system 1100 can include a large internal region in which acannula, when positioned therein, is unsupported as the cannula isadvanced distally therethrough. This region of relatively large internaldiameter(s) corresponds with the inner cavities of the connected hubs1180, 1106 (see FIG. 25). With reference to FIG. 36, embodiments of theaccess system 1300 can include a reinforcement member 1330 that includesa movable reinforcement cannula 1332. The reinforcement cannula 1332 ismovable relative to a connector 1302 so as to advanced distally intothis unsupported region of the catheter system 1100 and provide lateralsupport or reinforcement to a cannula 1304 as it is advanced distallythrough the hubs 1180, 1160 into the catheter tube 1104 of the cathetersystem 1100.

The cannula 1304 can be of any suitable construction, including thosediscussed elsewhere herein. For example, in some embodiments, thecannula 1304 includes at least a distal segment and a medial segmentformed in manners such as described elsewhere. The medical segment maybe intrinsically reinforced so as to resist or prevent kinking orbuckling thereat as the cannula 1304 is advanced distally.

FIG. 35 is a perspective view of the access system 1300 in a retractedor undeployed state. As noted, in some embodiments, the access system1300 can be particularly well-suited for use with open intravenouscatheter systems, and may further be well-suited for use with extensionsets coupled with such open intravenous catheter systems. The movablereinforcement tube 1332 can be said to support the cannula 1304 along atleast a portion of a length of the extension set, such as the extensionset 1150, and/or through a length of a catheter hub to which theextension set is coupled, such as the catheter hub 1106. FIG. 36 is across-sectional view of the access system 1300 in the retracted state.

FIG. 37A is a perspective view of an embodiment of the connector 1302,which includes a housing 1305 that is compatible with the access system1300. FIG. 37B is a perspective cross-sectional view of the housing ofFIG. 37A. The housing 1305 can define a proximal chamber 1390 and adistal chamber 1391. The distal chamber 1391 can have a larger innerdiameter than does the proximal chamber 1390. As discussed below, theproximal chamber 1390 can be narrower so as to define a restrictedregion, whereas the distal chamber 1391 can be relatively larger todefine an expanded region. In the illustrated embodiment, the proximalchamber 1390 includes a track 1364, similar to the anti-rotational track1064 discussed previously.

The housing 1305 can include a distal protrusion 1313 similar to likenumbered elements above. As discussed further below, the distalprotrusion or projection 1313 can cooperate with or support areinforcing member 1330 (see FIG. 36). The distal projection 1313 can befixed relative to the connector 1302. For example, the distal projection1313 may be integrally formed with at least a distal end tube of thehousing 1305. The distal projection 1313 may define an inner diameterthat is slightly larger than an outer diameter of the reinforcing tube1332. The reinforcing tube 1332 may be sized to slide through the distalprojection 1313. The distal projection 1313 may be viewed as a componentof the reinforcing member 1330. For example, the reinforcing member 1330can include both the distal projection 1313 and the reinforcing cannula1332. In various embodiments, at least a portion of the reinforcingmember 1330 is fixed relative to the housing 1305. In variousembodiments, at least a portion of the reinforcing member 1330 ismovable relative to the connector housing 1305.

FIG. 38A is a perspective view of an embodiment of a follower 1360 thatis compatible with the access system 1300. The follower 1360 can includea selective engagement feature that can engage with or disengage fromthe reinforcing cannula 1332. FIG. 38B is a cross-sectional view of thefollower 1360. The follower 1360 includes a selective engagementfeature, by which the follower 1360 can selectively engage andselectively disengage from the reinforcing cannula 1332. In particular,the follower 1360 includes a plurality of engagement arms 1392 havingdistal ends configured to interface with a catch 1393 attached to thereinforcing cannula 1332 (see FIG. 42). In particular, the engagementarms 1392 can each include an engagement protrusion 1394 that isconfigured to interface with the catch 1393 in manners such as describedbelow. In the illustrated embodiment, each engagement protrusion 1394includes an engagement face 1395. The engagement face 1395 may be aramped or angled surface. Each engagement face 1395 may be angled awayfrom a central longitudinal axis of the follower 1360, in aproximal-to-distal direction.

The follower 1360 can include an anti-rotation protrusion 1362, whichcan resemble the protrusion 1062 discussed above. The anti-rotationprotrusion 1362 may be configured to interface with the track 1364 ofthe housing 1305 in manners such as previously described. The follower1360 may further include a proximal cavity 1371 and an opening 1373,which may be similar to the proximal cavity 1071 and the opening 1073described above.

FIG. 39A is a perspective view of an embodiment of a reinforcementshuttle 1335 that includes the reinforcing tube 1332 and the catch 1393.FIG. 39B is a cross-sectional view of the reinforcement shuttle 1335.

The catch 1393 can be fixedly secured to a proximal end of thereinforcement tube 1332. The catch 1393 can define a recess 1337 that issized to receive the engagement protrusions 1394 of the engagement arms1392. In the illustrated embodiment, the recess 1337 is formed as anannular depression have a cross-sectional profile that is complementaryto a profile of each engagement protrusion 1394. The recess 1337 caninclude an engagement face 1339 that is configured to make contact withthe engagement faces 1395 of the engagement protrusions 1394. Theengagement face 1339 may be a ramped or angled surface. In particular,the engagement face 1339 can be angled away from a central longitudinalaxis of the reinforcement shuttle 1335, in a proximal-to-distaldirection. The ramped engagement faces 1339, 1395 of the catch 1393 andthe arms 1392 may be referred to as a ramped interface.

FIG. 40 is a cross-sectional view of a distal end of the access system1300 when in the retracted state. In the illustrated embodiment, when inthis operational state, a distal tip of the cannula 1304 is recessedrelative to a distal tip of the reinforcement cannula 1332, which isrecessed relative to a distal tip of the distal projection 1313.

FIG. 41 is a cross-sectional view of a larger distal region of theaccess system 1300 when in the retracted state. As shown, both thedistal projection 1313 and the reinforcement shuttle 1335, whichincludes the reinforcement cannula 1332, can be components of thereinforcement member 1300. These components cooperate to reinforce thecannula 1304 as it is advanced from the retracted position, in mannerssuch as discussed hereafter.

FIG. 42 is a cross-sectional view of an intermediate region of theaccess system 1300 when in the retracted state. As can be seen in thisview, the cannula 1304 can include a distal segment 1326 and a medialsegment 1324, which can resemble like-named and numbered featuresdiscussed elsewhere herein. For example, in some embodiments, the distalsegment 1326 can be formed of a polymeric tube (e.g., of polyimide). Insome embodiments, the medial segment 1324 includes a proximal extensionof the polymeric tube, and further includes a rigid tubular supportmember (e.g., of metallic construction) that encompasses the polymerictube. In other embodiments, the medial segment 1324 comprises a rigidtube (e.g., formed of metal) that includes a distal tip that abuts adistal tip of the polymeric tube; the abutting ends of the tubes may bejoined in any suitable fashion, such as via an overlying heat shrinktube. Other suitable arrangements are contemplated. The distal andmedial segments 1326, 1324 can meet at an interface 1352, which ispositioned within the reinforcement tube 1332 in the illustratedretracted state of the access system 1300.

In the illustrated retracted state (also depicted in FIG. 45), the catch1393 and the distal ends of the arms 1392 of the follower 1360, whichare coupled to the catch 1393, can be positioned within the proximalchamber 1390 of the housing 1305. The narrow inner sidewall of thehousing 1305 that defines the proximal chamber 1390 can constrain thearms 1392 so as to maintain the arms 1392 in a coupled state with thecatch 1393. In particular, the proximal chamber 1390 can be sized tomaintain the angled faces 1395, 1339 of the arms 1392 and the catch1335, respectively, engaged with each other. As further discussed below,this engagement of the angled faces may permit the arms 1392 of thefollower 1360 to urge the catch 1393 distally as the cannula 1304, towhich the follower 1360 is attached, is advanced distally.

In some embodiments, the arms 1392 may be resiliently biased outwardly,or away from the central longitudinal axis, so as to spring outwardlywhen no longer constrained within the proximal chamber 1390. In otherembodiments, the arms 1392 may be devoid of a bias. The arms 1392 may besufficiently flexible to be capable of being urged outwardly by theinteraction of the angled faces 1395, 1339 when distal advancement ofthe reinforcement shuttle 1335 is inhibited and when the arms 1392 arenot constrained within the proximal chamber 1390, as further discussedbelow.

FIG. 43 is a cross-sectional view of a generally proximal portion of theaccess system 1300 when in the retracted state. The follower 1360 can bepositioned at a proximal end of the housing 1305. The anti-rotationprotrusion 1362 can be positioned within the track 1364 of the housing1305. Further details of the cannula 1304, which can resemble othercannulas previously discussed, are also shown.

FIG. 44 is a cross-sectional view of the access system 1300 coupled withan embodiment of a base catheter assembly 1100 while the access system1300 is in the retracted state. The base catheter assembly 1100 includesthe open intravenous catheter 1101 and the extension set 1150 that iscoupled thereto, in manners such as previously described with respect toFIGS. 24 and 25.

FIG. 45 is a cross-sectional view of a generally intermediate region ofthe access system 1300 while in the coupled and retracted configurationdepicted in FIG. 44. FIG. 46 is a cross-sectional view of a distalportion of the access system 1300 while in the coupled and retractedstate, which further depicts a proximal portion of the catheter assembly1100. As shown in FIG. 46, the distal projection 1313 can extend asignificant distance within the hub 1180. However, as previouslydiscussed, a larger diameter region extends between the distal tip ofthe distal projection 1313 and the proximal tip of the catheter tube1104 within the hubs 1180, 1106. This is the region that is bridged bythe reinforcement tube 1332 as the access system 1300 is deployed, asfurther discussed below.

FIG. 47 is a cross-sectional view of the access system 1300 coupled withthe base catheter assembly 1100 while in a partially deployed state, orstated otherwise, while in an intermediate stage or state of deployment.The cannula 1304 has been advanced distally through a first distance,which in turn, has advanced the follower 1360 distally through thehousing 1305 by the same distance.

FIG. 48 is a cross-sectional view of an intermediate region of theaccess system 1300 while in the partially deployed state. In beingadvanced to the illustrated orientation, the arms 1392 have been andremain in a low-profile state, as constrained by the proximal chamber1390. This maintains contact between the ramped surfaces 1395, 1339. Theramped surfaces 1395 pushes against the ramped surface 1339 to advancethe reinforcement shuttle 1335 distally in unison with distaladvancement of the follower 1360 and the cannula 1304.

As shown, the distal ends of the arms 1392 have advanced distally pastthe end of the proximal chamber 1390 of the housing 1305 and haveentered the enlarged cavity of the distal chamber 1391. In theillustrated embodiment, the arms 1392 are not resiliently outwardlybiased, and thus do not automatically expand to an enlarged state whenno longer constrained in a low-profile orientation. A substantialproximal length of the arms 1392 remains positioned within the proximalchamber 1390 in the constrained state, such that the distal tips of thearms 1392 will generally remain in the low-profile state, even when inthe enlarged distal chamber 1391, unless and until they are urgedoutwardly. Stated otherwise, the distal ends of the arms 1392 are at aposition within the distal chamber 1391 at which they may be allowed tobe urged radially our laterally outwardly to an expanded profile.

FIG. 49 is a cross-sectional view of a distal end of the access system1300 and a proximal portion of the base catheter assembly 1100 while theaccess system 1300 is in the partially deployed state. At this point, adistal tip of the reinforcement tube 1332 has come into contact with theproximal tip 1107 of the catheter tube 1104. This contact can preventfurther distal advancement of the reinforcement tube 1332. In theillustrated configuration, the distal end of the cannula 1304 remainswithin the reinforcement tube 1332 until there is relative movementbetween the follower 1360 and the reinforcement shuttle 1335 (FIG. 48).

FIG. 50 is a cross-sectional view of the access system 1300 coupled withthe base catheter assembly 1100 while in fully deployed state. FIG. 51is a cross-sectional view of an intermediate region of the access system1300 while in the fully deployed state. In reaching this state, thereinforcement shuttle 1335 remains in the same configuration depicted inFIGS. 47-49. That is, the distal tip of the reinforcement tube 1330remains abutted against the proximal tip 1107 of the catheter tube 1104(FIG. 49). Note that in other embodiments, the reinforcement tube 1330may additionally or alternatively be sized to abut against an innersurface of the catheter hub 1106 (FIG. 49). As the cannula 1304 isadvanced distally relative to the orientation shown in FIGS. 47-49, thefollower 1360 moves distally in unison with the cannula 1304, to whichit is attached. The reinforcement tube 1104 and the catch 1393 that isattached thereto remain in a fixed position relative to the housing 1305due to interference between the reinforcement cannula 1332 and thecatheter tube 1104. The ramped or angled surfaces 1395 of the arms 1392press against the ramped or angled surface 1339 of the immobilized catch1393. The angled surfaces 1395 interact with the angled surface 1339 tourge the distal ends of the arms 1392 outwardly. The distal chamber 1391of the housing 1305 provides sufficient clearance to permit thedeflected ends of the arms 1392 to pass over the catch 1393 andresiliently return to the straightened state shown in FIG. 51. As thecannula 1304 is further advanced distally, the follower 1360 moves inunison with the cannula 1304 and the arms 1392 of the follower 1360 passover or by or beside the outer surface of the catch 1393.

In various embodiments, various parameters may be adjusted to permit thearms 1392 to disengage from and move distally relative to the catch 1393in manners such as just described. For example, in some embodiments, astiffness of the arms 1392 may be selected to ensure that disengagementonly occurs once threshold level of resistance to distal movement of thereinforcement tube 1332 is experienced. A relative orientation of theproximal and distal chambers 1390, 1391 of the housing 1305 may also oralternatively be adjusted. In various embodiments, the access system1300 may be configured for use with a variety of different base cathetersystems (with and/or without extension sets) that define a variety ofdifferent lengths through which the reinforcement tube 1332 passesbefore encountering resistance to forward advancement. Certainembodiments may permit the arms 1392 to remain engaged with the catch1393 until resistance is met at any of these various lengths and tothereafter disengage from the catch 1393.

FIG. 52 is a cross-sectional view of a generally distal portion of theaccess system 1300 and a proximal portion of the base catheter assembly1100 while the access system is in the fully deployed state. As shown,the distal tip of the reinforcement cannula 1332 remains engaged withand immobilized by the proximal tip 1107 of the catheter tube 1104throughout distal advancement of the cannula 1304 past the intermediateposition depicted in FIGS. 47-49. The cannula 1304 passes through theimmobilized reinforcement cannula 1332 and is reinforced thereby in theevent that resistance to distal movement of the cannula 1304 isencountered, such as at a bend or kink in the catheter tube 1304.

FIG. 53 is a cross-sectional view of distal ends of the access system1300 and the base catheter assembly 1100 while the access system 1300 isin the fully deployed state. In the illustrated embodiment, the cannula1304 extends past the distal tip of the catheter tube 1104.

FIG. 54 is a perspective view of another embodiment of an access system1400, and FIG. 55 is a cross-sectional view of the access system 1400.The access system 1400 is shown in both drawings in a retracted state.The access system 1400 includes a removable sterility cap 1494 that iscoupled to a connector 1402. The cap 1494 can be included with thepackaged access system 1400 and removed prior to use. The illustratedconnector 1402 includes a snap-fit arrangement, such as previouslydisclosed, for example, with respect to the access system 1200.

The access system 1400 may resemble the access system 1200 in manyrespects, and may be particularly suitable for use with a closedintravenous catheter system. As discussed above, the cannula 1204 of theembodiment of the access system 1200 illustrated in FIGS. 30-34 includestwo abutting tubes that are joined by heat-shrink tubing. However, othercannula configurations are disclosed with respect to the access system1200, including a cannula that includes a continuous polymeric tube anda support tube that encompasses at least an intermediate region of thepolymeric tube. The cannula 1204 of the access system 1400 is of thelatter configuration.

With reference to FIGS. 56A and 56B, the cannula 1404 can include aproximal segment 1422, a medial segment 1424, and a distal segment 1426.The cannula 1404 includes a central tube 1496 that defines the distalsegment 1426. The central tube 1496 extends continuously through themedial segment 1424. A proximal end of the central tube 1496 ispositioned in a portion of the proximal segment 1422. The proximalsegment 1422 further includes a proximal tube 1422 of any suitable form,such as described previously herein. The central tube 1496 may becoupled with the proximal tube 1422 in any suitable manner, such as by apress fit, adhesive, etc. At least the proximal tube 1422 may be fixedlysecured to a follower 1460.

The central tube 1496 may be formed of any suitable material, such asdisclosed with respect to other embodiments (e.g., a polymericmaterial). The central tube 1496 may be flexible. Embodiments of thecentral tube 1496 can be laterally flexible while having sufficientcolumnar or axial strength or rigidity to navigate or negotiate tortuouspaths through a catheter tube and/or sufficient radial strength toremain patent when within such tortuous paths. The medial segment 1424can further include a support tube 1495 that encompasses, encircles,sheathes, covers, overlays, etc. an intermediate portion of the centraltube 1496. The support tube 1495 may be relatively rigid, as previouslydiscussed. In some embodiments, the support tube 1495 may be metallic,such as a stainless steel hypotube. In some embodiments, the supporttube 1495 is fixedly secured to at least a proximal end of the centraltube 1496. In some embodiments, the support tube 1495 is adhered orotherwise secured to the central tube 1496 only at a proximal end of thesupport tube 1495. In other embodiments, the support tube 1495 may beadhered or otherwise secured to the central tube 1496 alongsubstantially an entire length of the support tube 1495. Otherarrangements are contemplated.

The support tube 1495 may have an inner diameter that is only slightly,narrowly, marginally, or minimally larger than; is approximately thesame as; conforms or substantially conforms with; and/or substantiallyinhibits, limits, and/or prevents lateral movements of an outer diameterof the central tube 1496. The support tube 1495 can be in a fixedlongitudinal relationship with the central tube 1496 so as to move inunison therewith, while preventing lateral movement of the central tube1496 within a lumen of the support tube 1495 that otherwise would bend,kink, and/or buckle the central tube 1496. In various embodiments, theinner diameter of the support tube 1495 is no greater than 5, 10, 15,20, 25, or 30 percent larger than the outer diameter of the central tube1496.

With reference to FIG. 56A, a distal tip or distal edge of the supporttube 1495 can correspond to a distal terminus 1450 of the medial segment1424. Although the central tube 1496 may extend continuously through thedistal terminus 1450, the medial and distal segments 1424, 1426 maystill be said to meet at an interface 1452 at the distal terminus 1450of the medial segment 1424.

As with other embodiments disclosed herein, in some embodiments, theinterface 1452 may be positioned within a reinforcement tube 1432 whenthe cannula 1404 is in the retracted state, as shown in FIG. 56A. As thecannula is advanced distally, the support tube 1495 moves in tandem withthe central tube 1496 that it encompasses and slides distally within thereinforcement tube 1432.

In some instances, the access system 1400 can be particularly wellsuited for use with closed catheter systems. The access system 1400 maybe coupled and used with the closed catheter system 700 in a manner suchas described above with respect to the access system 1200 in FIGS. 33and 34.

FIGS. 57 and 58 depict another embodiment of an access system 1500. Insome embodiments, the access system 1500 can be particularly well suitedfor use with an open catheter system, whether with or without anextension set. The access system 1500 can include a cannula 1504 that issubstantially the same as the cannula 1404 just discussed with respectto the access system 1400. In particular, the cannula 1404 can include acentral tube and a support member that encompasses the central tube.Other arrangements for the cannula 1504, including those discussedelsewhere herein, are also contemplated.

The access system 1500 can further include a sealing member 1600 coupledwith a reinforcement tube 1532 and the cannula 1504. An open cathetersystem may not include a sealing member or valve that could seal againstthe cannula 1504 during use. The sealing member 1600 can prevent bloodthat might pass proximally through an annular space between thereinforcement tube 1532 and the cannula 1504 from egressing from aproximal end of the reinforcement tube 1532 and into a housing of theaccess system 1500.

FIG. 59 provides a more detailed view of in internal portion of theaccess assembly 1500 that includes the sealing member 1600. The sealingmember 1600 can be fixedly secured to a proximal end of thereinforcement tube 1532. The proximal end of the sealing member caninclude a proximal opening 1602 through which a support tube 1595 of thecannula 1504 passes. The sealing member 1600 can form a static seal withthe reinforcement tube 1532 and can form a dynamic seal with the supporttube 1595. Stated otherwise, the sealing member 1600 can be in a fixedrelation relative to the reinforcement tube 1532, yet can permitmovement of the support tube 1595 relative thereto, while the sealingmember 1600 maintains a fluid tight seal with each of the reinforcementtube 1532 and the support tube 1595. The sealing member 1600 can preventblood from egressing from the support tube 1595 and through the proximalopening 1602.

FIG. 60 depicts another embodiment of a sealing member 1700, which canresemble the sealing member 1600 in many respects. The sealing member1700 includes a proximal opening 1702 and a strain-relief region 1704 ata proximal end of the sealing member 1700. In particular, a distal endof an internal cavity 1706 defined by the sealing member 1700 can have areduced diameter D1 at which the sealing member 1700 tightly grips thereinforcing member 1532 and forms a static, fluid-tight seal therewith.A proximal end of the internal cavity 1704 can have an undercut orexpanded region defining an expanded diameter D2. In the expandedproximal region, the sealing member 1700 may be recessed or spaced froman external surface of the reinforcement member 1532 when the accesssystem 1500 is fully assembled. This can, in some instances, permitreadier movement of the support tube 1595 through the proximal end ofthe sealing member 1700 as the support tube 1595 is moved through theproximal opening 1702, thus maintaining a secure, dynamic, fluid-tightseal between the sealing member 1700 and the support tube 1595. Theexpanded diameter can permit readier flexion of the proximal end of thesealing member 1700.

FIG. 61 is a perspective view of another embodiment of an access system1800 in a retracted state. FIG. 62 is a cross-sectional view of theaccess system 1800 in the retracted state. The access system 1800includes a tab 1898 that extends through a longitudinal track 1899 inthe housing element. The tab 1898 is attached to an internal coupler1861, that can resemble previously described followers in generalconfiguration, but can differ significantly therefrom in its connectionto the externally positioned tab 1898. The internal coupler 1861 mayalternatively be referred to as a follower, although it differs fromother followers herein described in at least one significant respect.Whereas the other followers move solely in response to forces applied tothe cannula, the internal coupler 1861 may additionally move in responseto forces applied to the tab 1898. Regardless, the internal coupler 1861does not instigate or otherwise cause movement of a cannula 1804 towhich it is attached. Movements of the internal coupler 1861 are purelypassive and in response to either movement of the cannula 1804 ormovement of the tab 1898. The internal coupler 1861 can be connectedwith portions of a cannula 1804, such that the cannula 1804 can be movedin response to movement of the tab 1898. The tab 1898 can be used tomove the internal coupler 1861 forwardly and rearwardly along thedesignated track 1898 and thereby advance and retract the cannula 1804.

FIG. 63 is a perspective cross-sectional view of another embodiment ofan access system 1900 that includes a deployable cannula 1904. FIG. 64is a cross-sectional view of a generally distal portion of the accesssystem 1900. The cannula 1904 includes a unitary central tube 1996(e.g., formed of a polymeric material) without any support tube attachedthereto. The central tube 1996 is attached at its proximal end to aproximal 1923. The access system 1900 includes a reinforcement member1930 at a distal end thereof that is defined by a connection member1970.

Methods of using embodiments of access systems are discussed above.Certain methods can include placing a base catheter system in thevasculature of a patient. Other or further methods can include couplingan access system with a pre-placed base catheter system. In certainembodiments, the base catheter system may be placed in one or more of adorsal arch of a hand, a forearm, or an antecubital fossa position on apatient. Various embodiments disclosed herein are capable for use withpre-placed base catheter systems that have been placed at any of theseregions. For example, the access systems may include supported cannulathat are capable of use with base catheter tubes that may definesignificantly tortuous paths.

In some instances, the base catheter system may be placed on the patientin a typical fashion that does not involve the use of special spacing ororientation apparatus. For example, some embodiments of access systemsmay be used with base catheter systems that have been taped down to theskin of the patient or secured to the skin of the patient with astandard flat dressing. There may be no spacing element present, such asa wedge-shaped device configured to provide an entry angle for theaccess system. That is, the access systems may be usable through atortuous region defined by a base catheter system that is taped orotherwise secured directly to the skin of the patient.

EXAMPLES

The present paragraph recites 322 illustrative examples of systems,kits, and methods that correspond with various embodiments of theforegoing written description and/or the illustrative drawings. In theseexamples, the terminology “Example X to Example Y” means Example Xthrough Example Y, and thus includes the endpoints of the recited rangeof examples.

Example 1. An access system comprising:

a connector configured to couple with a catheter assembly that comprisesa catheter tube configured to be positioned in a blood vessel of apatient;

a reinforcement member coupled with the connector; and

a cannula movable relative to the reinforcement member from a retractedposition in which at least a portion of the cannula is within thereinforcement member to an advanced position, the cannula comprising:

-   -   a first segment at a distal end of the cannula that defines a        distal tip of the cannula; and    -   a second segment that is relatively stiffer than the first        segment and extends proximally from the first segment, the        second segment comprising a distal terminus that is configured        to be within the reinforcement member when the distal tip of the        cannula is first positioned distal of and external to the        reinforcement member as the cannula is transitioned from the        retracted position to the advanced position,

wherein, when the connector and the catheter assembly are in a coupledstate, at least a portion of the first segment of the cannula isconfigured to be advanced through at least a portion of the cathetertube as the cannula is transitioned from the retracted position to theadvanced position.

Example 2. The access system of Example 1, wherein the catheter assemblyis configured to be preplaced in the patient such that the catheter tubeis positioned in the blood vessel of the patient prior to coupling ofthe connector of the access system with the catheter assembly.Example 3. The access system of Example 1 or Example 2, wherein, whenthe catheter tube of the catheter assembly is positioned in the bloodvessel of the patient and when the connector of the access system andthe catheter assembly are in the coupled state, advancement of thecannula to the advanced position enables fluid communication directlybetween the cannula and the blood vessel.Example 4. The access system of any one of Example 1 to Example 3,wherein when the cannula is in the advanced position, the distal tip ofthe cannula extends distally past a distal tip of the catheter tube.Example 5. The access system of any one of Example 1 to Example 3,wherein when the cannula is in the advanced position, the distal tip ofthe cannula is positioned within the catheter tube at or proximate to adistal tip of the catheter tube.Example 6. The access system of any one of Example 1 to Example 5,wherein when the cannula is in the advanced position, said at least aportion of the cannula is positioned outside of and distal to a distaltip of the reinforcement member.Example 7. The access system of any one of Example 1 to Example 6,wherein the second segment of the cannula is relatively harder than thefirst segment of the cannula.Example 8. The access system of any one of Example 1 to Example 7,wherein the second segment of the cannula comprises a flexible and/orpolymeric tube and a support member that is stiffer than and encompassesat least a portion of the flexible and/or polymeric tube.Example 9. The access system of Example 8, wherein at least a distal endof the support member is encompassed by the reinforcement member whenthe cannula is in the retracted position.Example 10. The access system of Example 8 or Example 9, wherein atleast an intermediate portion of the flexible and/or polymeric tube thatcontinuously extends along at least a portion of each of the first andsecond segments is encompassed by one or more of the reinforcementmember and the support member along a full length of the intermediateportion when the cannula is in the retracted position.Example 11. The access system of any one of Example 8 to Example 10,wherein the support member advances distally through the reinforcementmember throughout movement of the cannula from the retracted position tothe advanced position.Example 12. The access system of any one of Example 8 to Example 11,wherein the distal terminus comprises a distal tip of the supportmember.Example 13. The access system of any one of Example 8 to Example 12,wherein the flexible and/or polymeric tube fits snugly within thesupport member.Example 14. The access system of any one of Example 8 to Example 13,wherein the support member is fixed relative to the flexible and/orpolymeric tube.Example 15. The access system of Example 14, wherein the support memberis adhered to the flexible and/or polymeric tube.Example 16. The access system of any one of Example 8 to Example 15,wherein the flexible and/or polymeric tube extends through a full lengthof the support member.Example 17. The access system of any one of Example 8 to Example 16,wherein the support member extends along a full length of the secondsegment.Example 18. The access system of any one of Example 8 to Example 17,wherein the cannula further comprises a third segment that extendsproximally from the second segment.Example 19. The access system of Example 18, wherein the third segmentcomprises a proximal tube having an outer diameter that is larger thanan outer diameter of the flexible and/or polymeric tube.Example 20. The access system of Example 18 or Example 19, wherein theflexible and/or polymeric tube is fixedly secured to the proximal tube.Example 21. The access system of any one of Example 18 to Example 20,further comprising a follower attached to each of the second and thirdsegments.Example 22. The access system of any one of Example 8 to Example 20,wherein the first segment comprises a portion of the flexible and/orpolymeric tube.Example 23. The access system of Example 22, wherein the first segmentis formed exclusively from the flexible and/or polymeric tube.Example 24. The access system of Example 22, wherein the flexible and/orpolymeric tube is formed of a unitary piece of material that extendscontinuously from the first segment to the second segment.Example 25. The access system of any one of Example 8 to Example 24,wherein the flexible and/or polymeric tube is formed of polyimide.Example 26. The access system of any one of Example 8 to Example 25,wherein the support member comprises a support tube that circumscribesan outer surface of the flexible and/or polymeric tube.Example 27. The access system of Example 26, wherein the support tubecomprises a metallic materialExample 28. The access system of Example 27, wherein the support tube isformed of stainless steel.Example 29. The access system of any one of Example 8 to Example 28,wherein the support member is sized to slide through at least a portionof the reinforcement member as the cannula is transitioned from theretracted position to the advanced position.Example 30. The access system of any one of Example 8 to Example 29,further comprising a sealing member coupled to each of the reinforcementmember and the support member so as to form a fluid-tight seal toprevent ingress of fluid into or egress of fluid from a space betweenthe reinforcement member and the support member.Example 31. The access system of Example 30, wherein the sealing memberis fixedly secured to the reinforcement member and the support member ismovable relative to the sealing member.Example 32. The access system of Example 30 or Example 31, wherein thesealing member is attached to a proximal end of the reinforcementmember.Example 33. The access system of any one of Example 30 to Example 32wherein the sealing member encompasses a proximal tip of thereinforcement member.Example 34. The access system of any one of Example 8 to Example 33,wherein the reinforcement member defines a lumen that defines an innerdiameter that is no greater than 20 percent larger than an outerdiameter of the support member.Example 35. The access system of any one of Example 8 to Example 34,wherein the support member prevents kinking of the flexible and/orpolymeric tube when the first segment encounters force resistive todistal advancement of the distal tip of the cannula by preventinglateral movement of the flexible and/or polymeric tube within thesupport member in an amount that otherwise would be sufficient to kinkthe flexible and/or polymeric tube.Example 36. The access system of any one of Example 1 to Example 7,wherein the first segment comprises a first tube that comprises a firstend face, the second segment comprises a second tube that comprises asecond end face, and the first and second end faces abut one another atan interface positioned at the distal terminus of the second segment.Example 37. The access system of Example 36, wherein each of the firstand second end faces is transversely oriented relative to a longitudinalaxis of the cannula.Example 38. The access system of Example 36 or Example 37, wherein thesecond tube is stiffer than the first tube.Example 39. The access system of Example 38, wherein the second tube isformed of a metallic materialExample 40. The access system of Example 39, wherein the second tube isformed of stainless steel.Example 41. The access system of any one of Example 36 to Example 40,wherein the first tube is formed of a polymeric material.Example 42. The access system of any one of Example 36 to Example 41,further comprising a tie layer extending over the interface and at leasta portion of each of the first and second tubes of the first and secondsegments, respectively, to attach the first and second tubes together orto reinforce an attachment between the first and second tubes.Example 43. The access system of Example 42, wherein an outer diameterof the first tube and an outer diameter of the second tube aresubstantially identical in at least a region of the cannula thatincludes the interface.Example 44. The access system of Example 42 or Example 43, wherein anouter diameter of the tie layer is substantially constant along atransition region that includes a proximal end of the first segment, theinterface, and a distal end of the second segment.Example 45. The access system any one of Example 42 to Example 44,wherein the tie layer comprises a tubular member that defines athickness that is no less than five times smaller than a thickness ofthe first tube.Example 46. The access system of any one of Example 42 to Example 45,wherein the tie layer comprises a tube formed of heat shrinkablematerial.Example 47. The access system of any one of Example 42 to Example 46,wherein a hardness of the tie layer is less than a hardness of the firstsegment.Example 48. The access system of any one of Example 42 to Example 47,wherein a distal tip of the tie layer is proximally spaced from thedistal tip of the cannula, and wherein the distal tip of the tie layeris configured to contact an internal surface of the catheter tube todelimit proximal movement of the cannula relative to the catheter tube.Example 49. The access system of any one of Example 42 to Example 48,wherein a distal tip of the tie layer is proximally spaced from thedistal tip of the cannula, and wherein the distal tip of the tie layeris configured to contact an internal surface of the catheter tube toprovide tactile feedback to a user regarding a position of the cannularelative to the catheter tube.Example 50. The access system of any one of Example 1 to Example 49,wherein the reinforcement member prevents kinking of the first segmentwhen the first segment encounters force resistive to distal advancementof the distal tip of the cannula by preventing lateral movement of thefirst segment within the reinforcement member in an amount thatotherwise would be sufficient to kink the first segment.Example 51. The access system of any one of Example 1 to Example 50,wherein an inner diameter of the first segment is no greater than aninner diameter of the second segment.Example 52. The access system of any one of Example 1 to Example 50,wherein an inner diameter of the first segment and an inner diameter ofthe second segment are substantially identical in at least a region ofthe cannula that includes the terminus.Example 53. The access system of any one of Example 1 to Example 52,wherein the reinforcement member defines a lumen that defines an innerdiameter that is no greater than 20 percent larger than an outerdiameter of the first segment of the cannula.Example 54. The access system of Example 53, wherein the inner diameterof the lumen is constant along a tubular region that extends along atleast a portion of a full length of the reinforcement member.Example 55. The access system of Example 54, wherein the tubular regionextends to a distal tip of the reinforcement member.Example 56. The access system of Example 54 or Example 55, wherein thetubular region extends along at least a majority of the full length ofthe reinforcement member.Example 57. The access system of any one of Example 1 to Example 56,wherein the reinforcement member comprises a stainless steel tube.Example 58. The access system of Example 57, wherein the reinforcementmember further comprises a polymeric material overmolded onto thestainless steel tube.Example 59. The access system of any one of Example 1 to Example 56,wherein the connector and the reinforcement member are integrally formedof a unitary piece of material.Example 60. The access system of Example 59, wherein the unitary pieceof material is polymeric.Example 61. The access system of any one of Example 1 to Example 60,wherein the first segment is shorter than the reinforcement member.Example 62. The access system of any one of Example 1 to Example 60,wherein the first segment is longer than the reinforcement member.Example 63. The access system of any one of Example 1 to Example 62,wherein the distal tip of the cannula is positioned within thereinforcement member when the cannula is in the retracted position, suchthat the distal tip of the cannula is first positioned distal of andexternal to the reinforcement member only after the cannula has beenmoved from the retracted position.Example 64. The access system of any one of Example 1 to Example 62,wherein the distal tip of the cannula is first positioned distal of andexternal to the reinforcement member when the cannula is in theretracted position.Example 65. The access system of any one of Example 1 to Example 64,wherein the distal terminus of the second segment of the cannula iswithin the reinforcement member when the cannula is in the retractedposition.Example 66. The access system of any one of Example 1 to Example 65,wherein the distal terminus of the second segment of the cannula isdistal to a distal edge of the reinforcement member when the cannula isin the advanced position.Example 67. The access system of any one of Example 1 to Example 66,wherein the catheter assembly comprises an extension set that comprisesa hub, wherein the distal terminus of the second segment of the cannulais positioned within the hub when the cannula is in the advancedposition.Example 68. The access system of any one of Example 1 to Example 66,wherein the catheter assembly comprises a catheter hub coupled to thecatheter tube, wherein the distal terminus of the second segment of thecannula is positioned within the catheter hub when the cannula is in theadvanced position.Example 69. The access system of any one of Example 1 to Example 65,wherein the distal terminus of the second segment of the cannula iswithin the reinforcement member when the cannula is in the advancedposition.Example 70. The access system of any one of Example 1 to Example 65,wherein the distal terminus of the second segment of the cannula iswithin the reinforcement member throughout movement of the cannula fromthe retracted position to the advanced position.Example 71. The access system of any one of Example 1 to Example 70,further comprising a sheath coupled to the connector, wherein thecannula extends through at least a portion of the sheath, the cannulabeing movable relative to the sheath from the retracted position to theadvanced position.Example 72. The access system of Example 71, wherein at least a portionof the sheath and at least a portion of the connector are integrallyformed of a unitary piece of material.Example 73. The access system of Example 71 or Example 72, wherein, whenthe cannula is in each of the retracted and advanced positions, at leastsome portion of the cannula is positioned within the sheath.Example 74. The access system of any one of Example 71 to Example 73,wherein at least some portion of the cannula is positioned within thesheath throughout movement of the cannula from the retracted position tothe advanced position.Example 75. The access system of any one of Example 71 to Example 74,wherein the sheath comprises a tube having a proximal end and a distalend, and wherein the cannula extends through at least the proximal endof the sheath when in the retracted position and extends through atleast the distal end of the sheath when in the advanced position.Example 76. The access system of any one of Example 71 to Example 75,further comprising a follower fixedly attached to the cannula andpositioned within the sheath, wherein the follower moves in unison withthe cannula as the cannula is moved from the retracted position to theadvanced position.Example 77. The access system of Example 76, wherein the followercooperates with the sheath to delimit proximal movement of the cannularelative to the sheath.Example 78. The access system of Example 76 or Example 77, wherein thefollower and the sheath comprise a rotational alignment mechanism bywhich a rotational orientation of the cannula is maintained relative tothe sheath.Example 79. The access system of Example 78, wherein the rotationalalignment mechanism comprises a protrusion positioned within a groove,wherein the sheath defines one of the protrusion and the groove and thefollower defines the other of the protrusion and the groove.Example 80. The access system of any one of Example 76 to Example 79,wherein:

the reinforcement member comprises a reinforcing tube that is movablerelative to the connector;

the follower is coupled to the reinforcing tube while the cannula is inthe retracted position such that the follower and the reinforcing tubemove distally in tandem with the cannula throughout movement of thecannula from the retracted position to an intermediate position that isproximal of the advanced position; and

the follower is configured to decouple from the reinforcing tube as thecannula is moved distally past the intermediate position.

Example 81. The access system of Example 80, wherein when the followerdecouples from the reinforcing tube, the follower and the cannula arepermitted to move distally relative to the reinforcing tube while thereinforcing tube remains fixed relative to the connector.Example 82. The access system of Example 80 or Example 81, furthercomprising a catch fixedly attached to the reinforcing tube, wherein thefollower comprises a plurality of arms that grasp the catch throughoutmovement of the cannula from the retracted position to the intermediateposition and release the catch as the cannula is moved distally past theintermediate position.Example 83. The access system of Example 82, wherein:

the sheath comprises a first chamber that defines a first diameter and asecond chamber positioned distal of the first chamber that defines asecond diameter larger than the first diameter;

the first chamber of the sheath is sized to constrain at least distalends of the plurality of arms from flexing outwardly while the distalends are positioned in the first chamber such that the arms engage thecatch while in the first chamber; and

the second chamber of the sheath is sized to permit the distal ends ofthe plurality of arms to flex outwardly to disengage from the catch andto move distally past the catch.

Example 84. The access system of Example 83, wherein a proximal end ofthe second chamber is proximal of the intermediate position.Example 85. The access system of Example 83 or Example 84, wherein theplurality of arms are outwardly biased such that the distal ends of theplurality of arms automatically flex outwardly and disengage from thecatch when advanced through the second chamber of the sheath.Example 86. The access system of Example 83 or Example 84, wherein theplurality of arms and the catch comprise a ramped interface that causesthe distal ends of the plurality of arms to flex outwardly and disengagefrom the catch when positioned in the second chamber of the sheath andwhen the reinforcing tube encounters increased resistance to distalmovement as the cannula is advanced toward the advanced position.Example 87. The access system of any one of Example 71 to Example 86,further comprising an actuator attached to the cannula, wherein at leasta portion of the actuator is accessible external to the sheath so as tobe manipulated to move the cannula between the advanced and retractedpositions.Example 88. The access system of Example 87, wherein the sheathcomprises a longitudinally extending track, and wherein a portion of theactuator extends through the track.Example 89. The access system of any one of Example 71 to Example 88,wherein the cannula is moved from the retracted position to the advancedposition by directly contacting the cannula.Example 90. The access system of any one of Example 1 to Example 89,wherein the connector comprises a threaded region that is configured tocooperate with a complementary portion of the catheter assembly tosecurely couple the connector with the catheter assembly.Example 91. The access system of any one of Example 1 to Example 89,wherein the connector comprises at least two flaps that are configuredto cooperate with a portion of the catheter assembly to securely snapthe connector onto the catheter assembly.Example 92. The access system of any one of Example 1 to Example 91,wherein the cannula comprises a further connector at a proximal endthereof for connecting the cannula to a fluid transfer device.Example 93. The access system of Example 92, wherein the fluid transferdevice comprises a blood collection unit.Example 94. The access system of Example 92 of Example 93, wherein thefurther connector comprises a luer fitting.Example 95. The access system of any one of Example 1 to Example 94,wherein the cannula is further movable from the advanced position to theretracted position.Example 96. The access system of any one of Example 1 to Example 95,wherein when the cannula is in the advanced position, a length of thecannula extends through the reinforcement member.Example 97. The access system of Example 96, wherein the second segmentof the cannula defines at least a portion of the length of the cannulathat extends through the reinforcement member when the cannula is in theadvanced position.Example 98. The access system of any one of Example 1 to Example 97,wherein:

the catheter assembly comprises a septum; and

a distal tip of the reinforcement member is configured to be positionedproximal to the septum when the connector is attached to the catheterassembly.

Example 99. The access system of any one of Example 1 to Example 97,wherein:

the catheter assembly comprises a septum;

the reinforcement member comprises a projection that extends distallyfrom a surface of the connector; and

at least a portion of the projection of the reinforcement member isconfigured to extend through the septum of the catheter assembly whenthe connector is attached to the catheter assembly.

Example 100. The access system of Example 99, wherein the septumcomprises an opening that is in an unsealed state prior to insertion ofthe projection of the reinforcement member through the septum.Example 101. The access system of Example 100, wherein the projection ofthe reinforcement member is configured to be inserted through theopening of the septum.Example 102. The access system of any one of Example 99 to Example 101,wherein the projection extends distally past a distal end of theconnector.Example 103. The access system of any one of Example 99 to Example 101,wherein the projection is proximally recessed relative to a distal endof the connector.Example 104. The access system of any one of Example 99 to Example 104,wherein the catheter assembly further comprises a valve positioneddistal to the septum.Example 105. The access system of Example 104, wherein, when theconnector is coupled with the catheter assembly, no portion of thereinforcement member extends through the valve.Example 106. The access system of Example 104 or Example 105, wherein,when the connector is coupled with the catheter assembly, a distal tipof the reinforcement member is at or proximally spaced from a proximalsurface of the valve.Example 107. The access system of any one of Example 104 to Example 106,wherein, when the connector is coupled with the catheter assembly, aportion of the reinforcement member extends through the septum.Example 108. The access system of any one of Example 104 to Example 107,wherein, when the connector is coupled with the catheter assembly, thereinforcement member aims the cannula toward a sealable opening of thevalve such that the distal tip of the cannula is advanced through thesealable opening of the valve as the cannula is moved from the retractedposition to the advanced position.Example 109. The access system of Example 108, wherein the sealableopening is substantially centered relative to the valve, and wherein,when the connector is coupled with the catheter assembly, thereinforcement member is substantially centered so as to be aligned withthe sealable opening.Example 110. The access system of any one of Example 104 to Example 109,wherein, when the cannula is in the advanced position, at least aportion of the second segment of the cannula extends through the valve.Example 111. The access system of Example 110, wherein, when the cannulais in the advanced position, the distal terminus of the second segmentof the cannula is distal to the valve.Example 112. The access system of any one of Example 99 to Example 111,wherein the catheter assembly further comprises a removable piercingmember that extends through the septum and through the catheter tube toassist in positioning the catheter tube in the blood vessel of thepatient, and wherein the piercing member is configured to be removedfrom the catheter assembly prior to coupling the connector of the accesssystem with the catheter assembly.Example 113. The access system of Example 112, wherein the removablepiercing member further extends through the valve when extending throughthe septum and through the catheter tube.Example 114. The access system of any one of Example 1 to Example 97,wherein the catheter assembly is a closed intravenous catheter system.Example 115. The access system of Example 114, wherein the closedintravenous catheter system comprises an integrated side port throughwhich fluid may be transferred to or from the catheter tube.Example 116. The access system of any one of Example 1 to Example 97,wherein the catheter assembly is an open intravenous catheter system.Example 117. The access system of any one of Example 1 to Example 116,wherein an entirety of the reinforcement member is external to thecatheter tube when the connector is coupled with the catheter assembly.Example 118. The access system of Example 117, wherein the entirety ofthe reinforcement member remains external to the catheter tubethroughout movement of the cannula from the retracted position to theadvanced position.Example 119. The access system of any one of Example 1 to Example 118,wherein a distal tip of the reinforcement member is proximal to aproximal tip the catheter tube when the connector is coupled with thecatheter assembly.Example 120. The access system of Example 119, wherein the distal tip ofthe reinforcement member remains proximal to the proximal tip of thecatheter tube throughout movement of the cannula from the retractedposition to the advanced position.Example 121. The access system of Example 1, wherein the reinforcementmember is fixed relative to the connector.Example 122. The access system of Example 1, wherein the reinforcementmember comprises a first metallic hypotube, and wherein the secondsegment comprises a second metallic hypotube sized to translate withinthe first metallic hypotube.Example 123. The access system of Example 122, wherein each of the firstand second segments is at least partially defined by a unitary polymerictube, and wherein the second metallic hypotube encompasses a portion ofthe polymeric tube.Example 124. The access system of Example 122 or Example 123, wherein adistal tip of the second metallic hypotube defines the distal terminusof the second segment.Example 125. The access system of any one of Example 1 to Example 124,further comprising the catheter assembly.Example 126. A kit comprising:

an access system according to any one of Example 1 to Example 125; and

instructions for using the kit, the instructions comprising directionsto:

-   -   couple the connector to the catheter assembly while the catheter        tube of the catheter assembly is positioned in the blood vessel        of the patient; and    -   advance the cannula from the retracted position to the advanced        position.        Example 127. The kit of Example 126, wherein the instructions        for using the kit further comprise directions to:

couple a fluid transfer device to the cannula; and

draw blood from the blood vessel through the cannula and into the fluidtransfer device.

Example 128. A method of using the access system of any one of Example 1to Example 125, the method comprising:

coupling the connector to the catheter assembly while the catheter tubeof the catheter assembly is positioned in the blood vessel of thepatient; and

advancing the cannula from the retracted position to the advancedposition.

Example 129. An access system comprising:

a connector configured to couple with a catheter assembly that comprisesa catheter tube configured to be positioned in a blood vessel of apatient;

a reinforcement member coupled with the connector; and

a cannula movable relative to the reinforcement member from a retractedposition in which at least a portion of the cannula is within thereinforcement member to an advanced position, the cannula comprising:

-   -   a flexible and/or polymeric tube that defines a distal tip; and    -   a support tube that is stiffer than and encompasses a portion of        the flexible and/or polymeric tube, the support tube defining a        distal edge that is configured to be within the reinforcement        member when the distal tip of the flexible and/or polymeric tube        is first positioned distal of and external to the reinforcement        member as the cannula is transitioned from the retracted        position to the advanced position,

wherein, when the connector and the catheter assembly are in a coupledstate, at least a portion of the flexible and/or polymeric tube isconfigured to be advanced through at least a portion of the cathetertube as the cannula is transitioned from the retracted position to theadvanced position. By flexible and/or polymeric tube, it is meant thatin some embodiments, the cannula comprises a flexible tube (whether ornot the tube is polymeric), while in other or further embodiments, thecannula comprises a polymeric tube, which can have properties such asdescribed in the present disclosure.

Example 130. An access system comprising:

a connector configured to couple with a catheter assembly that comprisesa catheter tube configured to be positioned in a blood vessel of apatient;

a reinforcement member coupled with the connector; and

a cannula movable relative to the reinforcement member from a retractedposition in which at least a portion of the cannula is within thereinforcement member to an advanced position, the cannula comprising:

-   -   a flexible and/or polymeric tube that defines a distal tip; and    -   a support tube that encompasses a portion of the flexible and/or        polymeric tube, the support tube being in a fixed relationship        with the flexible and/or polymeric tube so as to move in unison        with the flexible and/or polymeric tube as the cannula is        transitioned from the retracted position to the advanced        position,

wherein, when the connector and the catheter assembly are in a coupledstate, at least a portion of the flexible and/or polymeric tube isconfigured to be advanced through at least a portion of the cathetertube as the cannula is transitioned from the retracted position to theadvanced position.

Example 131. An access system comprising:

a connector configured to couple with a catheter assembly that comprisesa catheter tube configured to be positioned in a blood vessel of apatient;

a reinforcement member coupled with the connector; and

a cannula movable relative to the reinforcement member from a retractedposition in which at least a portion of the cannula is within thereinforcement member to an advanced position, the cannula comprising:

-   -   a flexible and/or polymeric tube that defines a distal tip; and    -   a support tube that encompasses a portion of the flexible and/or        polymeric tube, the support tube defining a distal edge that is        proximally spaced from the distal tip of the flexible and/or        polymeric tube,

wherein, when the connector and the catheter assembly are in a coupledstate, at least a portion of the flexible and/or polymeric tube isconfigured to be advanced through at least a portion of the cathetertube as the cannula is transitioned from the retracted position to theadvanced position.

Example 132. The access system of any one of Example 129 to Example 131,wherein, at each stage throughout movement of the cannula from theretracted position to the advanced position, at least some portion ofthe support tube is positioned within the reinforcement member.Example 133. The access system of any one of Example 129 to Example 132,wherein the flexible and/or polymeric tube comprises polyimide.Example 134. The access system of any one of Example 129 to Example 133,wherein the distal edge of the support tube is configured to extenddistally past a distal tip of the reinforcement member when the cannulais in the advanced position.Example 135. The access system of any one of Example 129 to Example 134,wherein the distal tip of the flexible and/or polymeric tube ispositioned within the reinforcement member when the cannula is in theretracted position, such that the distal tip of the flexible and/orpolymeric tube is first positioned distal of and external to thereinforcement member only after the cannula has been moved from theretracted position.Example 136. The access system of any one of Example 129 to Example 134,wherein the distal tip of the flexible and/or polymeric tube is firstpositioned distal of and external to the reinforcement member when thecannula is in the retracted position.Example 137. The access system of any one of Example 129 to Example 136,wherein the distal edge of the support tube is within the reinforcementmember when the cannula is in the retracted position.Example 138. The access system of any one of Example 129 to Example 137,wherein the distal edge of the support tube is distal to a distal edgeof the reinforcement member when the cannula is in the advancedposition.Example 139. The access system of any one of Example 129 to Example 138,wherein the catheter assembly comprises an extension set that comprisesa hub, wherein the distal edge of the support tube is positioned withinthe hub when the cannula is in the advanced position.Example 140. The access system of any one of Example 129 to Example 138,wherein the catheter assembly comprises a catheter hub coupled to thecatheter tube, wherein the distal edge of the support tube is positionedwithin the catheter hub when the cannula is in the advanced position.Example 141. The access system of any one of Example 129 to Example 137,wherein the distal edge of the support tube is within the reinforcementmember when the cannula is in the advanced position.Example 142. The access system of Example 129 or Example 141, whereinthe distal edge of the support tube is within the reinforcement memberthroughout movement of the cannula from the retracted position to theadvanced position.Example 143. The access system of any one of Example 129 to Example 142,further comprising a sheath coupled to the connector, wherein thecannula extends through at least a portion of the sheath, the cannulabeing movable relative to the sheath from the retracted position to theadvanced position.Example 144. The access system of Example 143, wherein at least aportion of the sheath and at least a portion of the connector areintegrally formed of a unitary piece of material.Example 145. The access system of Example 143 or Example 144, wherein,when the cannula is in each of the retracted and advanced positions, atleast some portion of the cannula is positioned within the sheath.Example 146. The access system of any one of Example 143 to Example 145,wherein at least some portion of the cannula is positioned within thesheath throughout movement of the cannula from the retracted position tothe advanced position.Example 147. The access system of any one of Example 143 to Example 146,wherein the sheath comprises a tube having a proximal end and a distalend, and wherein the cannula extends through at least the proximal endof the sheath when in the retracted position and extends through atleast the distal end of the sheath when in the advanced position.Example 148. The access system of any one of Example 143 to Example 147,further comprising a follower fixedly attached to the cannula andpositioned within the sheath, wherein the follower moves in unison withthe cannula as the cannula is moved from the retracted position to theadvanced position.Example 149. The access system of Example 148, wherein the followercooperates with the sheath to delimit proximal movement of the cannularelative to the sheath.Example 150. The access system of Example 148 or Example 149, whereinthe follower and the sheath comprise a rotational alignment mechanism bywhich a rotational orientation of the cannula is maintained relative tothe sheath.Example 151. The access system of Example 150, wherein the rotationalalignment mechanism comprises a protrusion positioned within a groove,wherein the sheath defines one of the protrusion and the groove and thefollower defines the other of the protrusion and the groove.Example 152. The access system of any one of Example 129 to Example 151,wherein:

the catheter assembly comprises a septum; and

a distal tip of the reinforcement member is configured to be positionedproximal to the septum when the connector is attached to the catheterassembly.

Example 153. The access system of any one of Example 129 to Example 151,wherein:

the catheter assembly comprises a septum;

the reinforcement member comprises a projection that extends distallyfrom a surface of the connector; and

at least a portion of the projection of the reinforcement member isconfigured to extend through the septum of the catheter assembly whenthe connector is attached to the catheter assembly.

Example 154. The access system of Example 153, wherein the septumcomprises a sealable region that provides a fluid-tight seal prior toinsertion of the projection of the reinforcement member through thesealable region.Example 155. The access system of Example 153, wherein the septumcomprises an opening that is in an unsealed state prior to insertion ofthe projection of the reinforcement member through the septum.Example 156. The access system of Example 155, wherein the projection ofthe reinforcement member is configured to be inserted through theopening of the septum.Example 157. The access system of any one of Example 153 to Example 156,wherein the projection extends distally past a distal end of theconnector.Example 158. The access system of any one of Example 153 to Example 156,wherein the projection is proximally recessed relative to a distal endof the connector.Example 159. The access system of any one of Example 153 to Example 158,wherein the catheter assembly further comprises a valve positioneddistal to the septum.Example 160. The access system of Example 159, wherein, when theconnector is coupled with the catheter assembly, no portion of thereinforcement member extends through the valve.Example 161. The access system of Example 159 or Example 160, wherein,when the connector is coupled with the catheter assembly, a distal tipof the reinforcement member is at or proximally spaced from a proximalsurface of the valve.Example 162. The access system of any one of Example 159 to Example 161,wherein, when the connector is coupled with the catheter assembly, aportion of the reinforcement member extends through the septum.Example 163. The access system of any one of Example 159 to Example 162,wherein, when the connector is coupled with the catheter assembly, thereinforcement member aims the cannula toward a sealable opening of thevalve such that the distal tip of the flexible and/or polymeric tube isadvanced through the sealable opening of the valve as the cannula ismoved from the retracted position to the advanced position.Example 164. The access system of Example 163, wherein the sealableopening is substantially centered relative to the valve, and wherein,when the connector is coupled with the catheter assembly, thereinforcement member is substantially centered so as to be aligned withthe sealable opening.Example 165. The access system of any one of Example 153 to Example 164,wherein the catheter assembly further comprises a removable piercingmember that extends through the septum and through the catheter tube toassist in positioning the catheter tube in the blood vessel of thepatient, and wherein the piercing member is configured to be removedfrom the catheter assembly prior to coupling the connector of the accesssystem with the catheter assembly.Example 166. The access system of any one of Example 159 to Example 165,wherein the removable piercing member further extends through the valvewhen extending through the septum and through the catheter tube.Example 167. The access system of any one of Example 129 to Example 166,wherein the catheter assembly is a closed intravenous catheter system.Example 168. The access system of Example 167, wherein the closedintravenous catheter system comprises an integrated side port throughwhich fluid may be transferred to or from the catheter tube.Example 169. The access system of any one of Example 129 to Example 166,wherein the catheter assembly is an open intravenous catheter system.Example 170. The access system of any one of Example 129 to Example 169,further comprising a sealing member coupled to each of the reinforcementmember and the support tube so as to form a fluid-tight seal to preventingress of fluid into or egress of fluid from a space between thereinforcement member and the support tube.Example 171. The access system of Example 170, wherein the sealingmember is fixedly secured to the reinforcement member and the supporttube is movable relative to the sealing member.Example 172. The access system of Example 170 or Example 171, whereinthe sealing member is attached to a proximal end of the reinforcementmember.Example 173. The access system of any one of Example 170 to Example 172wherein the sealing member encompasses a proximal tip of thereinforcement member.Example 174. The access system of any one of Example 129 to Example 173,further comprising the catheter assembly.Example 175. A kit comprising:

an access system according to any one of Example 129 to Example 174; and

instructions for using the kit, the instructions comprising directionsto:

-   -   couple the connector to the catheter assembly while the catheter        tube of the catheter assembly is positioned in the blood vessel        of the patient; and    -   advance the cannula from the retracted position to the advanced        position.        Example 176. The kit of Example 175, wherein the instructions        for using the kit further comprise directions to:

couple a fluid transfer device to the cannula; and

draw blood from the blood vessel through the cannula and into the fluidtransfer device.

Example 177. A method of using the access system of any one of Example129 to Example 174, the method comprising:

coupling the connector to the catheter assembly when the catheter tubeof the catheter assembly is positioned in the blood vessel of thepatient; and

advancing the cannula from the retracted position to the advancedposition.

Example 178. An access system comprising:

a connector configured to couple with a closed intravenous cathetersystem that comprises a valve and a catheter tube that is configured tobe positioned in a blood vessel of a patient;

a reinforcement member coupled with the connector such that when theconnector is coupled with the closed intravenous catheter system, adistal tip of the reinforcement member is at or proximally spaced from aproximal surface of the valve; and

a cannula movable relative to the reinforcement member from a retractedposition to an advanced position,

wherein, when the connector and the closed intravenous catheter systemare in a coupled state, at least a portion of the cannula is configuredto be advanced through the valve and through at least a portion of thecatheter tube as the cannula is transitioned from the retracted positionto the advanced position.

Example 179. An access system comprising:

a connector configured to couple with a closed intravenous cathetersystem that comprises a valve and a catheter tube that is configured tobe positioned in a blood vessel of a patient;

a reinforcement member coupled with the connector such that when theconnector is coupled with the closed intravenous catheter system, noportion of the reinforcement member is in contact with the valve; and

a cannula movable relative to the reinforcement member from a retractedposition to an advanced position,

wherein, when the connector and the closed intravenous catheter systemare in a coupled state, at least a portion of the cannula is configuredto be advanced through the valve and through at least a portion of thecatheter tube as the cannula is transitioned from the retracted positionto the advanced position.

Example 180. An access system comprising:

a connector configured to couple with a closed intravenous cathetersystem that comprises a valve and a catheter tube that is configured tobe positioned in a blood vessel of a patient;

a reinforcement member coupled with the connector such that when theconnector is coupled with the closed intravenous catheter system, noportion of the reinforcement member extends through the valve; and

a cannula movable relative to the reinforcement member from a retractedposition to an advanced position,

wherein, when the connector and the closed intravenous catheter systemare in a coupled state, at least a portion of the cannula is configuredto be advanced through the valve and through at least a portion of thecatheter tube as the cannula is transitioned from the retracted positionto the advanced position.

Example 181. The access system of any one of Example 178 to Example 180,wherein the closed intravenous catheter system is configured to bepreplaced in the patient such that the catheter tube is positioned inthe blood vessel of the patient prior to coupling of the connector ofthe access system with the closed intravenous catheter system.Example 182. The access system of any one of Example 178 to Example 181,wherein, when the catheter tube of the closed intravenous cathetersystem is positioned in the blood vessel of the patient and when theconnector of the access system and the closed intravenous cathetersystem are in the coupled state, advancement of the cannula to theadvanced position enables fluid communication directly between thecannula and the blood vessel.Example 183. The access system of any one of Example 178 to Example 182,wherein when the cannula is in the advanced position, a distal tip ofthe cannula extends distally past a distal tip of the catheter tube.Example 184. The access system of any one of Example 178 to Example 182,wherein when the cannula is in the advanced position, a distal tip ofthe cannula is positioned within the catheter tube at or proximate to adistal tip of the catheter tube.Example 185. The access system of any one of Example 178 to Example 184,wherein when the cannula is in the advanced position, at least a portionof the cannula is positioned outside of and distal to a distal tip ofthe reinforcement member.Example 186. The access system of any one of Example 178 to Example 185,wherein the cannula comprises a first segment at a distal end thereofand a second segment that extends proximally from the first segment andis relatively stiffer than the first segment.Example 187. The access system of Example 186, wherein the secondsegment of the cannula comprises a flexible and/or polymeric tube and asupport member that encompasses at least a portion of the flexibleand/or polymeric tube.Example 188. The access system of Example 187, wherein the supportmember is in a fixed relation relative to the flexible and/or polymerictube so as to move in unison therewith.Example 189. The access system of Example 187 or Example 188, wherein atleast a distal end of the support member is encompassed by thereinforcement member when the cannula is in the retracted position.Example 190. The access system of any one of Example 187 to Example 189,wherein at least an intermediate portion of the flexible and/orpolymeric tube that continuously extends along at least a portion ofeach of the first and second segments is encompassed by one or more ofthe reinforcement member and the support member along a full length ofthe intermediate portion.Example 191. The access system of any one of Example 187 to Example 190,wherein the support member advances distally through the reinforcementmember throughout movement of the cannula from the retracted position tothe advanced position.Example 192. The access system of any one of Example 187 to Example 191,wherein a distal tip of the support member corresponds with a distalterminus of the second segment.Example 193. The access system of any one of Example 187 to Example 192,wherein the flexible and/or polymeric tube fits snugly within thesupport member.Example 194. The access system of any one of Example 187 to Example 193,wherein the support member is fixedly secured to the flexible and/orpolymeric tube.Example 195. The access system of Example 194, wherein the supportmember is adhered to the flexible and/or polymeric tube.Example 196. The access system of any one of Example 187 to Example 195,wherein the flexible and/or polymeric tube extends through a full lengthof the support member.Example 197. The access system of any one of Example 187 to Example 196,wherein the support member extends along a full length of the secondsegment.Example 198. The access system of any one of Example 187 to Example 197,wherein:

the cannula further comprises a third segment that extends proximallyfrom the second segment;

the third segment comprises a proximal tube having an outer diameterthat is larger than an outer diameter of the flexible and/or polymerictube; and

the flexible and/or polymeric tube is fixedly secured to the proximaltube.

Example 199. The access system of any one of Example 187 to Example 198,wherein the first segment comprises a portion of the flexible and/orpolymeric tube.Example 200. The access system of Example 199, wherein the first segmentis formed exclusively from the flexible and/or polymeric tube.Example 201. The access system of Example 199, wherein the flexibleand/or polymeric tube is formed of a unitary piece of material thatextends continuously from the first segment to the second segment.Example 202. The access system of any one of Example 187 to Example 201,wherein the flexible and/or polymeric tube is formed of polyimide.Example 203. The access system of any one of Example 187 to Example 202,wherein the support member comprises a support tube that circumscribesan outer surface of the flexible and/or polymeric tube.Example 204. The access system of Example 203, wherein the support tubeis formed of stainless steel.Example 205. The access system of any one of Example 187 to Example 204,wherein the support member is sized to slide through at least a portionof the reinforcement member as the cannula is transitioned from theretracted position to the advanced position.Example 206. The access system of any one of Example 187 to Example 205,wherein the reinforcement member defines a lumen that defines an innerdiameter that is no greater than 20 percent larger than an outerdiameter of the support member.Example 207. The access system of any one of Example 187 to Example 206,wherein the support member prevents kinking of the flexible and/orpolymeric tube when the first segment encounters force resistive todistal advancement of the distal tip of the cannula by preventinglateral movement of the flexible and/or polymeric tube within thesupport member in an amount that otherwise would be sufficient to kinkthe flexible and/or polymeric tube.Example 208. The access system of Example 186, wherein the first segmentcomprises a first tube that comprises a first end face, the secondsegment comprises a second tube that comprises a second end face, andthe first and second end faces abut one another at an interfacepositioned at the distal terminus of the second segment.Example 209. The access system of Example 208, wherein each of the firstand second end faces is transversely oriented relative to a longitudinalaxis of the cannula.Example 210. The access system of Example 208 or Example 209, whereinthe second tube is formed of stainless steel.Example 211. The access system of any one of Example 208 to Example 210,wherein the first tube is formed of a polymeric material.Example 212. The access system of any one of Example 208 to Example 211,further comprising a tie layer extending over the interface and at leasta portion of each of the first and second tubes of the first and secondsegments, respectively, to attach the first and second tubes together orto reinforce an attachment between the first and second tubes.Example 213. The access system of Example 212, wherein an outer diameterof the first tube and an outer diameter of the second tube aresubstantially identical in at least a region of the cannula thatincludes the interface.Example 214. The access system of Example 212 or Example 213, wherein anouter diameter of the tie layer is substantially constant along atransition region that includes a proximal end of the first segment, theinterface, and a distal end of the second segment.Example 215. The access system any one of Example 212 to Example 214,wherein the tie layer comprises a tubular member that defines athickness that is no less than 20 times smaller than a thickness of thefirst tube.Example 216. The access system of any one of Example 212 to Example 215,wherein the tie layer comprises a tube formed of heat shrinkablematerial.Example 217. The access system of any one of Example 212 to Example 216,wherein a hardness of the tie layer is less than a hardness of the firstsegment.Example 218. The access system of any one of Example 212 to Example 217,wherein a distal tip of the tie layer is proximally spaced from thedistal tip of the cannula, and wherein the distal tip of the tie layeris configured to contact an internal surface of the catheter tube todelimit proximal movement of the cannula relative to the catheter tube.Example 219. The access system of any one of Example 212 to Example 218,wherein a distal tip of the tie layer is proximally spaced from thedistal tip of the cannula, and wherein the distal tip of the tie layeris configured to contact an internal surface of the catheter tube toprovide tactile feedback to a user regarding a position of the cannularelative to the catheter tube.Example 220. The access system of any one of Example 178 to Example 219,wherein the reinforcement member prevents kinking of the cannula whenthe cannula encounters force resistive to distal advancement of a distaltip of the cannula by preventing lateral movement of the cannula withinthe reinforcement member in an amount that otherwise would be sufficientto kink the cannula.Example 221. The access system of any one of Example 178 to Example 220,wherein the reinforcement member defines a lumen that defines an innerdiameter that is no greater than 20 percent larger than an outerdiameter of a distal portion of the cannula.Example 222. The access system of Example 221, wherein the innerdiameter of the lumen is constant along a tubular region that extendsalong at least a majority of a full length of the reinforcement member.Example 223. The access system of any one of Example 178 to Example 222,wherein a distal tip of the cannula is positioned within thereinforcement member when the cannula is in the retracted position, suchthat the distal tip of the cannula is first positioned distal of andexternal to the reinforcement member only after the cannula has beenmoved from the retracted position.Example 224. The access system of any one of Example 178 to Example 222,wherein a distal tip of the cannula is first positioned distal of andexternal to the reinforcement member when the cannula is in theretracted position.Example 225. The access system of any one of Example 178 to Example 224,wherein the cannula comprises a first distal segment that is relativelysofter than a second segment that is proximally adjacent to the firstsegment, and wherein the second segment comprises a distal terminus thatis within the reinforcement member when the cannula is in the retractedposition.Example 226. The access system of any one of Example 178 to Example 225,wherein the distal terminus of the second segment of the cannula iswithin the reinforcement member when the cannula is in the advancedposition.Example 227. The access system of Example 225 or Example 226, whereinthe distal terminus of the second segment of the cannula is within thereinforcement member throughout movement of the cannula from theretracted position to the advanced position.Example 228. The access system of any one of Example 178 to Example 225,wherein the distal terminus of the second segment of the cannula isdistal to a distal tip of the reinforcement member when the cannula isin the advanced position.Example 229. The access system of any one of Example 178 to Example 227,further comprising a sheath coupled to the connector, wherein thecannula extends through at least a portion of the sheath, the cannulabeing movable relative to the sheath from the retracted position to theadvanced position.Example 230. The access system of Example 229, wherein at least aportion of the sheath and at least a portion of the connector areintegrally formed of a unitary piece of material.Example 231. The access system of Example 229 or Example 230, wherein,when the cannula is in each of the retracted and advanced positions, atleast some portion of the cannula is positioned within the sheath.Example 232. The access system of any one of Example 229 to Example 231,wherein at least some portion of the cannula is positioned within thesheath throughout movement of the cannula from the retracted position tothe advanced position.Example 233. The access system of any one of Example 229 to Example 232,wherein the sheath comprises a tube having a proximal end and a distalend, and wherein the cannula extends through at least the proximal endof the sheath when in the retracted position and extends through atleast the distal end of the sheath when in the advanced position.Example 234. The access system of any one of Example 229 to Example 233,further comprising a follower fixedly attached to the cannula andpositioned within the sheath, wherein the follower moves in unison withthe cannula as the cannula is moved from the retracted position to theadvanced position.Example 235. The access system of Example 234, wherein the followercooperates with the sheath to delimit proximal movement of the cannularelative to the sheath.Example 236. The access system of Example 234 or Example 235, whereinthe follower and the sheath comprise a rotational alignment mechanism bywhich a rotational orientation of the cannula is maintained relative tothe sheath.Example 237. The access system of Example 236, wherein the rotationalalignment mechanism comprises a protrusion positioned within a groove,wherein the sheath defines one of the protrusion and the groove and thefollower defines the other of the protrusion and the groove.Example 238. The access system of any one of Example 229 to Example 237,further comprising an actuator attached to the cannula, wherein at leasta portion of the actuator is accessible external to the sheath so as tobe manipulated to move the cannula between the advanced and retractedpositionsExample 239. The access system of Example 238, wherein the sheathcomprises a longitudinally extending track, and wherein a portion of theactuator extends through the track.Example 240. The access system of any one of Example 229 to Example 239,wherein the cannula is devoid of an actuator.Example 241. The access system of any one of Example 229 to Example 240,wherein the cannula is moved from the retracted position to the advancedposition by directly contacting the cannula.Example 242. The access system of any one of Example 178 to Example 241,wherein the connector comprises a snap-fit arrangement that isconfigured to snap onto a hub of the closed intravenous catheter systemto securely couple the connector to the closed intravenous cathetersystem.Example 243. The access system of Example 242, wherein the snap-fitarrangement comprises two or more flexible flaps that are configured toselectively attach to the hub of the closed intravenous catheter system.Example 244. The access system of any one of Example 178 to Example 243,wherein:

the closed intravenous catheter system further comprises a septum spacedfrom the valve; and

a distal tip of the reinforcement member is configured to be positionedproximal to the septum when the connector is attached to the closedintravenous catheter system.

Example 245. The access system of any one of Example 178 to Example 243,wherein:

the closed intravenous catheter system comprises a septum spaced fromthe valve;

the reinforcement member comprises a projection that extends distallyfrom a surface of the connector; and

at least a portion of the projection of the reinforcement member isconfigured to extend through the septum of the closed intravenouscatheter system when the connector is attached to the closed intravenouscatheter system.

Example 246. The access system of Example 245, wherein the septumcomprises an opening that is in an unsealed state prior to insertion ofthe projection of the reinforcement member through the septum.Example 247. The access system of Example 246, wherein the projection ofthe reinforcement member is configured to be inserted through theopening of the septum.Example 248. The access system of any one of Example 245 to Example 247,wherein the projection extends distally past a distal end of theconnector.Example 249. The access system of any one of Example 245 to Example 247,wherein the projection is proximally recessed relative to a distal endof the connector.Example 250. The access system of any one of Example 178 to Example 249,wherein, when the connector is coupled with the closed intravenouscatheter system, the reinforcement member aims the cannula toward asealable opening of the valve such that the distal tip of the cannula isadvanced through the sealable opening of the valve as the cannula ismoved from the retracted position to the advanced position.Example 251. The access system of Example 250, wherein the sealableopening is substantially centered relative to the valve, and wherein,when the connector is coupled with the closed intravenous cathetersystem, the reinforcement member is substantially centered so as to bealigned with the sealable opening.Example 252. The access system of any one of Example 178 to Example 251,wherein the closed intravenous catheter system further comprises aremovable piercing member that extends through the valve and through thecatheter tube to assist in positioning the catheter tube in the bloodvessel of the patient, and wherein the piercing member is configured tobe removed from the closed intravenous catheter system prior to couplingthe connector of the access system with the closed intravenous cathetersystem.Example 253. The access system of any one of Example 178 to Example 252,wherein the closed intravenous catheter system comprises an integratedside port through which fluid may be transferred to or from the cathetertube.Example 254. The access system of Example 253, wherein the side portcomprises an extension tube and a further connector attached to aproximal end of the extension tube.Example 255. The access system of Example 254, wherein no portion of thecannula passes through the extension tube as the cannula moves betweenthe retracted position and the advanced position.Example 256. The access system of any one of Example 178 to Example 255,wherein the closed intravenous catheter system comprises a hub thatdefines a cavity, and wherein the valve is positioned within the cavity.Example 257. The access system of Example 256, further comprising aseptum positioned at a proximal end of the cavity and spaced from thevalve.Example 258. The access system of Example 257, wherein the septumdefines a permanent opening and the valve defines a sealable openingthat are aligned with a longitudinal axis that extends through thecatheter tube.Example 259. The access system of Example 258, wherein the closedintravenous catheter system further comprises a piercing member thatextends through the openings of the septum and the valve and furtherextends through the catheter tube, and wherein the piercing member isconfigured to be removed from the catheter tube, the valve, and theseptum prior to coupling of the connector with the closed intravenousline.Example 260. The access system of Example 258 or Example 259, wherein adistal tip of the cannula is advanced substantially rectilinearlythrough the septum, the valve, and into the catheter tube as the cannulais transitioned from the retracted position toward the advancedposition.Example 261. The access system of any one of Example 257 to Example 260,wherein the reinforcement member extends through the septum when theconnector is coupled with the closed intravenous catheter system.Example 262. The access system of any one of Example 178 to Example 261,wherein the cannula comprises a first segment at a distal end thereofand a second segment that extends proximally from the first segment,wherein the second segment is stiffer than the first segment.Example 263. The access system of Example 262, wherein at least aportion of the second segment extends through the valve when the cannulais in the advanced position.Example 264. The access system of Example 262 or Example 263, whereinthe second segment comprises a rigid tube that encompasses a flexibletube.Example 265. The access system of Example 264, wherein the rigid tube isformed of a metallic material and wherein the flexible tube is formed ofa polymeric material.Example 266. The access system of any one of Example 178 to Example 265,further comprising the closed intravenous catheter system.Example 267. A kit comprising:

an access system according to any one of Example 178 to Example 266; and

instructions for using the kit, the instructions comprising directionsto:

-   -   couple the connector to the closed intravenous catheter system        while the catheter tube of the closed intravenous catheter        system is positioned in the blood vessel of the patient; and    -   advance the cannula from the retracted position to the advanced        position.        Example 268. The kit of Example 267, wherein the instructions        for using the kit further comprise directions to:

couple a fluid transfer device to the cannula; and

draw blood from the blood vessel through the cannula and into the fluidtransfer device.

Example 269. A method of using the access system of any one of Example178 to Example 266, the method comprising:

coupling the connector to the closed intravenous catheter system whilethe catheter tube of the closed intravenous catheter system ispositioned in the blood vessel of the patient; and

advancing the cannula from the retracted position to the advancedposition.

Example 270. An access system comprising:

a connector configured to couple with an implement port of a catheterassembly that is configured to transition from an insertionconfiguration to an access configuration, the catheter assemblycomprising:

-   -   a hub comprising the implement port, an access port, and a        cavity, the implement port being configured to permit a piercing        implement to extend therethrough when the catheter assembly is        in the insertion configuration;    -   a catheter tube coupled to the hub, the catheter tube defining a        first lumen in fluid communication with the cavity, the first        lumen being configured to receive at least a portion of the        piercing implement therein when the catheter assembly is in the        insertion configuration, the catheter tube being configured for        insertion in a blood vessel of a patient;    -   an extension tube coupled to the access port of the hub, the        extension tube defining a second lumen in fluid communication        with the cavity; and    -   a valve coupled to the hub, the valve being configured to be in        an open state when the piercing implement extends therethrough        while the catheter assembly is in the insertion configuration,        the valve further being configured to transition to a closed        state to prevent fluid communication between the cavity and the        implement port upon removal of the piercing implement from the        sealing member;

a cannula coupled to the connector and configured to be moved relativeto the connector from a retracted position to an advanced position, thecannula being sized to extend through at least a portion of the cathetertube when in the advanced position to provide access to blood within theblood vessel when the catheter tube is within the blood vessel; and

a reinforcement member sized to permit a portion of the cannula to beadvanced therethrough as the cannula is advanced from the retractedposition to the advanced position, wherein the reinforcement membersatisfies one or more of the following conditions when the connector iscoupled with the implement port of the catheter assembly:

-   -   a distal tip of the reinforcement member is positioned at a        proximal face of the valve without being embedded in the valve;    -   the distal tip of the reinforcement member is spaced proximally        from the proximal face of the valve;    -   no portion of the reinforcement member is in contact with the        valve; or    -   no portion of the reinforcement member extends through the        valve.        Example 271. The access system of Example 270, wherein the        cannula comprises a polymeric tube and a rigid support member        that encompasses a portion of the polymeric tube, and wherein        the support member is sized such that at least a portion of the        support member passes through the reinforcement member as the        cannula is moved to the advanced position.        Example 272. The access system of Example 270 or Example 271,        further comprising the catheter assembly.        Example 273. The access system of any one of Example 270 to        Example 272, wherein the catheter assembly further comprises the        piercing implement.        Example 274. The access system of any one of Example 270 to        Example 273, wherein the piercing implement comprises a needle.        Example 275. An access system comprising:

a connector configured to couple with a catheter assembly that comprisesa catheter tube configured to be positioned in a blood vessel of apatient;

a cannula movable relative to the connector from a retracted position toan intermediate position and from the intermediate position to anadvanced position, the cannula comprising a distal tip; and

a reinforcement tube that encompasses at least the distal tip of thecannula and is releasably connected to the cannula so as to move intandem with the cannula throughout movement of the cannula from theretracted position to the intermediate position, the reinforcement tubeand the cannula being configured to disconnect from each other at theintermediate position to permit the cannula to advance distally throughthe reinforcement tube as the cannula is transitioned from theintermediate position to the advanced position.

Example 276. The access system of Example 275, wherein, when theconnector and the catheter assembly are in a coupled state, at least thedistal tip of the cannula is configured to be advanced through at leasta portion of the catheter tube as the cannula is moved to the advancedposition.Example 277. The access system of Example 275 or Example 276, whereinthe reinforcement tube becomes substantially stationary relative to theconnector when the cannula passes through the intermediate position.Example 278. The access system of Example 277, wherein the reinforcementtube remains substantially stationary relative to the connector as thecannula transitions from the intermediate position to the advancedposition.Example 279. The access system of any one of Example 275 to Example 278,further comprising an arm attached to the cannula and a catch attachedto the reinforcing tube, wherein the arm engages the catch throughoutmovement of the cannula from the retracted position to the intermediateposition and disengages from the catch as the cannula is moved distallypast the intermediate position.Example 280. The access system of Example 279, further comprising asheath that comprises a first chamber defining a first diameter and asecond chamber positioned distal of the first chamber and defining asecond diameter larger than the first diameter,

wherein the first chamber of the sheath is sized to constrain at least adistal end of the arm from flexing outwardly while positioned in thefirst chamber such that the arm engages the catch while in the firstchamber, and

wherein the second chamber of the sheath is sized to permit the distalend of the arm to flex outwardly to disengage from the catch and to movedistally past the catch.

Example 281. The access system of Example 280, wherein a proximal end ofthe second chamber is proximal of the intermediate position.Example 282. The access system of Example 280 or Example 281, whereinthe arm is outwardly biased such that the distal end of the armautomatically flexes outwardly and disengages from the catch whenadvanced through the second chamber of the sheath.Example 283. The access system of Example 280 or Example 281, whereinthe arm and the catch comprise a ramped interface that causes the distalend of the arm to flex outwardly and disengage from the catch whenpositioned in the second chamber of the sheath and when the reinforcingtube encounters increased resistance to distal movement as the cannulais advanced toward the advanced position.Example 284. An access system comprising:

a connector configured to couple with a catheter assembly that includesa catheter tube preplaced into a blood vessel of a patient; and

a cannula movable relative to the connector from a retracted state to adeployed state, the cannula comprising at least a distal portion that isconfigured to be advanced through at least a portion of the cathetertube as the cannula is transitioned from the retracted state to theadvanced state, the cannula comprising:

-   -   a first segment at a distal end of the cannula;    -   a second segment attached to the first segment at an interface,        the first segment being relatively softer than the second        segment; and    -   a tie layer extending over the interface and at least a portion        of each of the first and second segments to attach the first and        second segments together or to reinforce an attachment between        the first and second segments.        Example 285. The access system of Example 284, wherein the        second segment comprises a metal tube.        Example 286. The access system of Example 284 or Example 285,        wherein a distal tip of the tie layer is proximally spaced from        the distal tip of the cannula, and wherein the distal tip of the        tie layer is configured to contact an internal surface of the        catheter tube to delimit proximal movement of the cannula        relative to the catheter tube.        Example 287. The access system of any one of Example 284 or        Example 286, wherein a distal tip of the tie layer is proximally        spaced from the distal tip of the cannula, and wherein the        distal tip of the tie layer is configured to contact an internal        surface of the catheter tube to provide tactile feedback to a        user regarding a position of the cannula relative to the        catheter tube.        Example 288. The access system of any one of Example 284 or        Example 288, further comprising the catheter assembly.        Example 289. A method comprising:

coupling an access system that comprises a reinforcement member and amovable cannula with a preplaced closed catheter system that comprises avalve and a catheter tube that is positioned within a blood vessel of apatient, said coupling comprising securing the access system to thepreplaced closed catheter system such that at least one of the followingconditions is satisfied:

-   -   a distal tip of the reinforcement member is fixed at a position        that is at a proximal end of the valve;    -   the distal tip of the reinforcement member is fixed at a        position that is proximally recessed from a proximal end of the        valve;    -   no portion of the reinforcement member is in contact with the        valve; or    -   no portion of the reinforcement member extends through the        valve; and

advancing the cannula of the access system from a position inside thereinforcement member through the valve of the closed catheter system andthrough at least a portion of the catheter tube.

Example 290. The method of Example 289, wherein the closed cathetersystem comprises a valve assembly that includes the valve and furtherincludes a septum positioned proximal to the valve.Example 291. The method of Example 290, wherein said coupling comprisesadvancing the distal tip of the reinforcement member of the accesssystem through the septum before the distal tip is fixed at the positionthat is at or proximally recessed from a proximal end of the valve.Example 292. The method of any one of Example 289 to Example 291,wherein the reinforcement member comprises a tube.Example 293. The method of any one of Example 289 to Example 292,wherein said coupling is achieved without making any contact between thereinforcement member and the valve.Example 294. The method of any one of Example 289 to Example 293,wherein said coupling is achieved without advancing any portion of thereinforcement member into or through the valve.Example 295. The method of any one of Example 289 to Example 294,wherein the valve of the closed catheter system comprises a closableopening that is configured to permit a piercing element to extendtherethrough during insertion of the catheter tube into the blood vesselof the patient, wherein the sealable region is in a self-sealed statewith the piercing element having been removed therefrom during saidcoupling, and wherein said advancing the cannula comprises advancing thecannula through the closable opening of the valve.Example 296. The method of any one of Example 289 to Example 295,wherein said advancing the cannula is achieved without advancing thedistal tip of the reinforcement member distally past the proximal end ofthe valve.Example 297. The method of any one of Example 289 to Example 296,wherein said advancing the cannula is achieved without contacting thereinforcement member to the valve.Example 298. The method of any one of Example 289 to Example 297,wherein said advancing the cannula is achieved without extending thereinforcement member through any portion of the valve.Example 299. The method of any one of Example 289 to Example 298,wherein the closed catheter system further comprises a hub coupled withthe catheter tube at a first port of the hub, wherein an extension tubeis coupled with a second port of the hub, and wherein a third port ofthe hub comprises the valve.Example 300. The method of Example 299, wherein said coupling the accesssystem with the preplaced closed catheter system comprises coupling aconnector of the access system with the third port of the hub.Example 301. The method of Example 299 or Example 300, wherein saidadvancing the cannula comprises advancing a distal portion of thecannula through the third port of the hub then through the first port ofthe hub and into the catheter tube.Example 302. The method of any one of Example 299 to Example 301,wherein the hub of the preplaced closed catheter system is secureddirectly to the skin of the patient.Example 303. The method of Example 302, wherein said coupling and saidadvancing are achieved without moving the hub of the preplaced cathetersystem relative to the skin of the patient.Example 304. The method of Example 302 or Example 303, wherein the hubof the preplaced closed catheter system is positioned flat against theskin of the patient without any other element (e.g., wedge-shaped orotherwise) being present between the hub and the skin of the patient.Example 305. The method of any one of Example 302 to Example 304,wherein a portion of the catheter tube is positioned within an insertionsite that extends through the skin of the patient, and wherein saidcoupling and said advancing are achieved without contacting an externalsurface of one or more of the hub or the catheter tube to adjust aposition of the portion of the catheter tube that extends through theinsertion site.Example 306. The method of any one of Example 289 to Example 305,wherein the access system further comprises an additional connector at aproximal end of the cannula, and wherein the method further comprises:

coupling a fluid collection device to the additional connector; and

after said advancing the cannula of the access system, drawing bloodthrough the cannula into the fluid collection device.

Example 307. The method of Example 306, further comprising, after saiddrawing blood, retracting the cannula of the access system from thecatheter tube.Example 308. The method of Example 307, further comprising, after saidretracting the cannula, decoupling the access system from the preplacedclosed catheter system.Example 309. The method of Example 307 or Example 308, furthercomprising, after said retracting the cannula, power injecting fluidinto the patient via the preplaced closed catheter system.Example 310. The method of any one of Example 289 to Example 309,wherein the catheter tube of the preplaced closed catheter system isinserted into a vein of the patient at any one of a dorsal arch of ahand, a forearm, or an antecubital fossa position.Example 311. An access system comprising:

a connector configured to couple with a catheter assembly that includesa catheter tube preplaced into a blood vessel of a patient;

a reinforcement tube fixedly secured to the connector; and

a cannula movable relative to the connector from a retracted state to adeployed state, the cannula comprising:

-   -   a distal segment that comprises at least a portion of a flexible        and/or polymeric tube; and    -   a medial segment that extends proximally from the distal        segment, the medial segment comprising a metal tube sized to        pass through the reinforcement tube,

wherein, when the cannula is in the retracted state, a distal tip of themedial segment is positioned within the reinforcement tube.

Example 312. The access system of Example 311, wherein the reinforcementtube is metallic.Example 313. The access system of Example 312, wherein the reinforcementtube comprises stainless steel.Example 314. The access system of any one of Example 311 to Example 313,wherein at least a portion of the metal tube of the medial segment ispositioned within the reinforcement tube throughout movement of thecannula from the retracted state to the deployed state.Example 315. The access system of any one of Example 311 to Example 314,wherein a portion of the metal tube of the medial segment extendsdistally beyond a distal tip of the reinforcement tube when the cannulais in the deployed state.Example 316. The access system of any one of Example 311 to Example 315,wherein the flexible and/or polymeric tube of the distal segmentcomprises at least one of polyimide, polyamide, PEEK, and polyurethane.Example 317. The access system of any one of Example 311 to Example 316,wherein the distal segment is configured to extend through the cathetertube such that at least a distal end of the distal segment extendsdistally beyond a distal tip of the catheter tube when the cannula is inthe deployed state.Example 318. The access system of any one of Example 311 to Example 317,wherein the metal tube of the medial segment and the flexible and/orpolymeric tube of the distal segment are joined together via heat shrinktubing.Example 319. The access system of any one of Example 311 to Example 317,wherein the flexible and/or polymeric tube is longer than the firstsegment of the cannula, wherein the distal segment comprises a firstportion of the flexible and/or polymeric tube, and wherein the medialsegment comprises a second portion of the flexible and/or polymeric tubethat extends continuously and proximally from the first portion of theflexible and/or polymeric tube.Example 320. The access system of Example 319, wherein the metal tube ofthe medial segment encompasses the second portion of the flexible and/orpolymeric tube.Example 321. The access system of Example 320, wherein the metal tube ofthe medial segment comprises an inner tubular surface that approximatesan outer tubular surface of the second portion of the flexible and/orpolymeric tube to thereby support the second portion of the flexibleand/or polymeric tube.Example 322. The access system of Example 320 or Example 321, whereinthe metal tube of the medial segment prevents one or more of bending,buckling, or kinking of the second portion of the flexible and/orpolymeric tube when the flexible and/or polymeric tube encountersproximally directed resistive forces as the cannula is advanced from theretracted state to the deployed state.

Any suitable combination of the various features of the variousembodiments and examples disclosed herein is contemplated. The term“coupled to” can mean connected to in any suitable fashion, whether thatcoupling is direct or indirect. Separate components may be coupled toeach other. Moreover, in some instances, where separately identifiedcomponents are integrally formed from a unitary piece of material, orstated otherwise, are included together in a monolithic element, thoseelements may also be said to be coupled to one another.

Although the foregoing detailed description contains many specifics forthe purpose of illustration, a person of ordinary skill in the art willappreciate that many variations and alterations to the following detailscan be made and are considered to be included herein. Accordingly, theforegoing embodiments are set forth without any loss of generality to,and without imposing limitations upon, any claims set forth. It is alsoto be understood that the terminology used herein is for the purpose ofdescribing particular embodiments only, and is not intended to belimiting. Unless defined otherwise, all technical and scientific termsused herein have the same meaning as commonly understood by one ofordinary skill in the art to which this disclosure belongs.

The claims following this written disclosure are hereby expresslyincorporated into the present written disclosure, with each claimstanding on its own as a separate embodiment. This disclosure includesall permutations of the independent claims with their dependent claims.Moreover, additional embodiments capable of derivation from theindependent and dependent claims that follow are also expresslyincorporated into the present written description. These additionalembodiments are determined by replacing the dependency of a givendependent claim with the phrase “any one of claims [x] through theimmediately preceding claim,” where the bracketed term “[x]” is replacedwith the number of the most recently recited independent claim. Forexample, for the first claim set that begins with independent claim 1,claim 3 can depend from either of claims 1 and 2, with these separatedependencies yielding two distinct embodiments; claim 4 can depend fromany one of claim 1, 2, or 3, with these separate dependencies yieldingthree distinct embodiments; claim 5 can depend from any one of claim 1,2, 3, or 4, with these separate dependencies yielding four distinctembodiments; and so on.

Recitation in the claims of the term “first” with respect to a featureor element does not necessarily imply the existence of a second oradditional such feature or element. Elements specifically recited inmeans-plus-function format, if any, are intended to be construed inaccordance with 35 U.S.C. § 112(f). Elements not presented in requisitemeans-plus-function format are not intended to be construed inaccordance with 35 U.S.C. § 112(f). Embodiments of the invention inwhich an exclusive property or privilege is claimed are defined asfollows.

1. An access system comprising: a connector configured to couple with acatheter assembly that comprises a catheter tube configured to bepositioned in a blood vessel of a patient; a reinforcement memberfixedly secured to the connector; and a cannula movable relative to thereinforcement member from a retracted position in which at least aportion of the cannula is within the reinforcement member to an advancedposition, the cannula comprising: a polymeric tube that defines a distaltip; and a support tube that encompasses a portion of and is stifferthan the polymeric tube, the support tube defining an inner diameterthat is marginally larger than an outer diameter of the polymeric tubeso as to prevent kinking of the polymeric tube, the support tube beingin a fixed relationship with the polymeric tube so as to move in unisontherewith, the support tube defining a distal edge that is proximallyspaced from the distal tip of the polymeric tube and that is configuredto be within the reinforcement member when the distal tip of thepolymeric tube is first positioned distal of and external to thereinforcement member as the cannula is transitioned from the retractedposition to the advanced position, wherein, when the connector and thecatheter assembly are in a coupled state, at least a portion of thepolymeric tube that extends distally beyond the distal edge of thesupport tube is configured to be advanced through at least a portion ofthe catheter tube as the cannula is transitioned from the retractedposition to the advanced position.
 2. The access system of claim 1,wherein the inner diameter of the support tube is larger than the outerdiameter of the polymeric tube by no greater than 30 percent.
 3. Theaccess system of claim 1, wherein, at each stage throughout movement ofthe cannula from the retracted position to the advanced position, atleast some portion of the support tube is positioned within thereinforcement member.
 4. The access system of claim 1, wherein, whereinthe distal edge of the support tube is configured to extend distallypast a distal tip of the reinforcement member when the cannula is in theadvanced position.
 5. The access system of claim 1, wherein the distaledge of the support tube is within the reinforcement member when thecannula is in the retracted position.
 6. The access system of claim 1,wherein the distal edge of the support tube is distal to a distal tip ofthe reinforcement member when the cannula is in the advanced position.7. The access system of claim 1, further comprising a sheath coupled tothe connector, wherein the cannula extends through at least a portion ofthe sheath, the cannula being movable relative to the sheath from theretracted position to the advanced position.
 8. The access system ofclaim 1, wherein the catheter assembly comprises a valve.
 9. The accesssystem of claim 8, wherein, when the connector is coupled with thecatheter assembly, no portion of the reinforcement member extendsthrough the valve.
 10. The access system of claim 8, wherein, when theconnector is coupled with the catheter assembly, a distal tip of thereinforcement member is at or proximally spaced from a proximal surfaceof the valve.
 11. The access system of claim 8, wherein, when theconnector is coupled with the catheter assembly, the reinforcementmember aims the cannula toward a sealable opening of the valve such thatthe distal tip of the polymeric tube is advanced through the sealableopening of the valve as the cannula is moved from the retracted positionto the advanced position.
 12. The access system of claim 11, wherein thesealable opening is substantially centered relative to the valve, andwherein, when the connector is coupled with the catheter assembly, thereinforcement member is substantially centered so as to be aligned withthe sealable opening.
 13. The access system of claim 1, wherein thecatheter assembly further comprises a removable piercing member thatextends through the valve and through the catheter tube to assist inpositioning the catheter tube in the blood vessel of the patient, andwherein the piercing member is configured to be removed from thecatheter assembly prior to coupling the connector of the access systemwith the catheter assembly.
 14. The access system of claim 1, whereinthe catheter assembly is one of a closed intravenous catheter system andan open intravenous catheter system.
 15. The access system of claim 1,further comprising a sealing member coupled to each of the reinforcementmember and the support tube so as to form a fluid-tight seal to preventegress of fluid from a space between the support tube and thereinforcement member.
 16. The access system of claim 1, wherein thesealing member is fixedly secured to the reinforcement member and thesupport tube is movable relative to the sealing member.
 17. The accesssystem of claim 1, further comprising the catheter assembly.
 18. A kitcomprising: the access system of claim 1; and instructions for using thekit, the instructions comprising directions to: couple the connector tothe catheter assembly while the catheter tube of the catheter assemblyis positioned in the blood vessel of the patient; and advance thecannula from the retracted position to the advanced position.
 19. Thekit of claim 18, wherein the instructions for using the kit furthercomprise directions to: couple a fluid transfer device to the cannula;and draw blood from the blood vessel through the cannula and into thefluid transfer device.
 20. A method of using the access system of claim1, the method comprising: coupling the connector to the catheterassembly when the catheter tube of the catheter assembly is positionedin the blood vessel of the patient; and advancing the cannula from theretracted position to the advanced position.